Profession Update Archives

Note: Documents provided on this website are in PDF format and require Adobe Reader. These documents will open in a new window.

(Note:Under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing.)

Note: This information is provided in the most accessible format possible. To request a more accessible version of the documents on this page, please send an email to MQA_Pharmacy@doh.state.fl.us.

FDA MedWatch - September 2008 Drug Safety-Related Labeling Changes for 36 Drugs Now Available on Web

The September 2008 posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES. The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/safety/2008/sep08_quickview.htm

FDA MedWatch- Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator- Class I Recall Because Of Unsupported Claims

FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Vibe

FDA MedWatch - The November 2008 Patient Safety News Is Now Available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

FDA Issues Final Rule Requiring Toll-Free Number on Medication Labeling

Food and Drug Administration (FDA) has issued a final rule requiring the labeling for certain medications to include a toll-free number for patients to report side effects. The final rule confirms the interim final rule “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products” and its requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. The statement must include a toll-free number and advise that the number is to be used only for reporting side effects and is not intended for medical advice. This final rule also affirms the interim final rule’s addition of a new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Food and Dug Administration Amendments Act of 2007. The final rule is effective November 28, 2008, and the compliance date is July 1, 2009. More information is available in the Federal Register [Docket No. FDA-2003-N-0313 ].

FDA Creates Web Page with Medication Safety Information for Patients, Professionals

Patients and health care professionals can now go to a single page on the Food and Drug Administration (FDA) Web site to find a wide variety of safety information about prescription medications. The Web page provides links to information on drug labeling; drugs that have a Risk Evaluation and Mitigation Strategy to ensure that their benefits outweigh their risks; post-market studies of drugs’ safety, efficacy, or optimal use; clinical trials; drug-specific safety information; warning letters; and consumer articles. Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007 and is among FDA's efforts to address the safe use of medications throughout their lifecycle. FDA recently launched another Web page that provides information on risks involved in using unapproved drugs. The new page has sections tailored to the interests of health care professionals, patients, and industry audiences, as well as links to general information for all audiences.

Methamphetamine Production Prevention Act of 2008 Signed into Law

President Bush signed into law Senate (S) Bill 1276, the Methamphetamine Production Prevention Act of 2008, on October 14, 2008. Now known as Public Law No. 110-415, the legislation revises the logbook requirements of the federal Combat Methamphetamine Epidemic Act, enacted in 2006, which limits the amount of methamphetamine precursor drugs, such as pseudoephedrine, that a patient can buy and requires pharmacies to keep written or electronic logbooks recording each purchase of the drugs. The new law changes the earlier act to facilitate the use of electronic logbooks instead of written logbooks and provides grants to accomplish this goal. The new system is intended to provide law enforcement with easier access to information and streamline recordkeeping requirements for pharmacies.

President Bush Signs Ryan Haight Act, Cracks Down on Internet Drug Outlets

President Bush signed into law House of Representatives (HR) Bill 6353, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 on October 15, 2008. Now known as Public Law No. 110-425, the new law amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. The law defines "valid prescription" as one issued for a legitimate purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. The legislation also adds definitions to the Controlled Substances Act relating to online pharmacies and the issuance of prescriptions over the Internet, imposes registration and reporting requirements on online pharmacies, and increases criminal penalties involving Schedule III, IV, and V controlled substances. The law also authorizes states to apply for injunctions or obtain damages and other civil remedies against online pharmacies that are deemed a threat to state residents.

FDA MedWatch- Thoratec HeartMate II Left Ventricular Assist System- Device Correction: Wear And Fatigue Of The Percutaneous Lead Connecting The Blood Pump With The System Controller May Cause Serious Injury Or Death

Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding the above issue. http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate

FDA MedWatch: Transvaginal Placement of Surgical Mesh- Serious Complications Associated With Transvaginal Placement Of Surgical Mesh In Repair of Pelvic Organ Prolapse And Stress Urinary Incontinence

FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh

MedWatch - Raptiva (efalizumab): Boxed Warning describes risk for life-threatening infections

FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva. Read the complete MedWatch 2008 Safety summary, including links to the FDA press release and the revised prescribing information, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Raptiva

FDA MedWatch- Dextroamphetamine Sulfate 5mg Tablets- Drug Recall Due To The Potential For Oversized Tablets

Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Dextroamphetamine

FDA MedWatch - Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes

FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo.

Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

Read the complete MedWatch 2008 Safety summary, including a link both todays update and the original March 18th Early Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium

FDA MedWatch- OTC Cough and Cold Medicines- Product Labels Being Modified To State " Do Not Use" In Children Under 4 Years Of Age
FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Press Release regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#CoughCold

FDA MedWatch- Nebion HLX-8 Magnetic Resonance Device: Device Not Approved By FDA
FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Class I Recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion

FDA MedWatch- Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit- Class I Recall
Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA (pdf - 27kb)

FDA Drug Safety Podcasts: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers

FDA MedWatch -Mobile Oxygen Storage Tank- Class I Recall Because The Device's Pressure Gauge May Rupture And May Catch Fire
Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall Notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Pacific

FDA MedWatch - The September 2008 FDA Patient Safety News is now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. This special edition repeats some of the most important safety issues that continue to pose a public health problem. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

MedWatch - Tumor necrosis factor-alpha blockers: delays in diagnosis of fungal and other opportunistic infections
Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals
FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.  For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. 

MedWatch - Disposable Battery Operated Lavage System: risk of explosion and harm to patients and staff
FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert.

FDA MedWatch-  Rituzan (rituximab)- Important New Safety Information Regarding Progressive Multifocal Leukoencephalopathy With The Use Of Rituxan
Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.

FDA MedWatch- LifePak CR Plus Automated External Defibrillators- Class I Recall Because The Shock Button Is Not Visible Which Impedes Responder's Ability To Provide Shock Therapy
Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.

FDA MedWatch -Infant Formula Manufactured in China: Health Information Advisory Due To Reports Of Possible Contamination With Melamine
FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.

Intra-articular Use In Children
Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.!

FDA MedWatch- FDA Drug Safety Newsletter- Summer 2008 Edition Available For Healthcare Professionals And The Medical Community
The Drug Safety Newsletter is a FDA publication for healthcare professionals and the medical community. The newsletter provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research. The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.

FDA MedWatch - Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% - Particulate matter detected in product

Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul. Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 -- a representative is available 24 hours, seven days a week.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Provider Letter, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ammonul

FDA MedWatch - Tarceva (erlotinib) - Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

Read the entire 2008 MedWatch Safety Summary, including links to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Tarceva, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva

FDA MedWatch - Epoetin alfa- Preliminary Safety Findings Show More Deaths In Patients Given Epoetin-alpha Versus Placebo

FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About An Ongoing Safety Review regarding this issue: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3

FDA MedWatch - Statin drugs and risk of amyotrophic lateral sclerosis (ALS)

An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.
Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA New Release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin

FDA MedWatch - The October 2008 FDA Patient Safety News Video is now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

FDA Issues Health Information Advisory on Infant Formula

In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.

The FDA is advising caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States as mentioned below. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.

The FDA began investigating the reports of contamination immediately and received information from the companies who manufacture infant formula for the American market that they are not importing infant formula or source materials from China. The following manufacturers have met the necessary FDA requirements for marketing milk-based infant formulas in the United States: Abbott Nutritionals, Mead Johnson Nutritionals, Nestle USA, PBM Nutritionals, and Solus Products LLC. Also, one manufacturer, SHS/Nutricia, Liverpool, England, markets an amino acid based exempt infant formula that does not contain any milk-derived ingredients.
We are asking state officials to work with the Agency to assist with the removal of any Chinese infant formula found on store shelves, and to warn members of the Asian community to avoid using Chinese manufactured infant formula.

It has been reported that a number of infants in China who have consumed Chinese manufactured infant formula are suffering from kidney stones, a condition which is rare in infants. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can causes kidney diseases such as those seen in these Chinese infants.

FDA requires that all infant formula manufacturers register with the Agency and adhere to specific labeling and nutritional requirements. All properly registered infant formula manufacturers marketing infant formula in the United States undergo an annual inspection of their production facilities.

Governor Crist issues >Executive Order 08-187, September 5, 2008 regarding Emergency Management for Hurricane Ike

Governor Crist issued Executive Order 08-187 , declaring a state of emergency for the entire State of Florida due to the threat that Hurricane Ike imposes to the state
Section 4, paragraph D, of the executive order authorizes pharmacists in areas or counties covered under this executive order to dispense up to a 30-day emergency prescription refill in accordance with section 465.0275, Florida Statutes.

Further, section 8, of the executive order provides that medical professionals and workers, social workers, and counselors with good and valid professional licenses issued by states other than the State of Florida may render such services in Florida during this emergency for persons affected by this emergency with the condition that such services be rendered to such persons free of charge, and with the further condition that such services be rendered under the auspices of the America Red Cross or the Florida Department of Health.

Additionally, please note that section 252.358, Florida Statutes, requires that all health insurers, managed care organizations, and other entities that are licensed by the Office of Insurance Regulation and provide prescription medication coverage as part of a policy or contract waive time restrictions on prescription medication refills, which include suspension of electronic "refill too soon" edits to pharmacies, to enable insureds or subscribers to refill prescriptions in advance, if there are authorized refills remaining, and shall authorize payment to pharmacies for at least a 30-day supply of any prescription medication, regardless of the date upon which the prescription had most recently been filled by a pharmacist, when the following conditions occur: The person seeking the prescription medication refill resides in a county that is under a hurricane warning issued by the National Weather Service, is declared to be under a state of emergency in an executive order issued by the Governor, or has activated its emergency operations center and its emergency management plan.

DOH PRESS RELEASE: Medications in Disaster Situations

TALLAHASSEE– In the event of a tropical storm or hurricane, you may need to evacuate your home and regular services may be temporarily limited. To ensure that you are able to continue taking your medications under such circumstances, the Florida Department of Health (DOH) recommends that you plan now by taking the following measures:

• Call your doctor now and request a 30-day supply of medication if possible.
• Get a pill organizer and pack enough pills for two weeks. Get assistance from your caregiver or medical professional in making sure you have packed enough of the medications you will need.
• Make a list of all your medications: how they should be taken, what time, etc. Make copies of the list. Put one copy with the medications; give one to a friend, and keep one with you at all times. Make sure to list any allergies, as well as foods you need to avoid. Your doctor’s name and emergency phone number should also be on this list. Your medical professional or caregiver should be able to assist you in this.
• Pack your medications now to have ready to carry with you at a moment’s notice.
• If you are taking prescription narcotic pain medications, keep them with you at all times.
• If you are on a special diet or require special supplements, take a two-week supply with you.
• Over the counter items that you should also bring with you: Pain reliever/ Ibuprofen, antacid, laxative/suppository, Imodium, Benadryl, decongestant, antibiotic ointment, lubricating eye drops.
• If you are using respiratory medications with a nebulizer, bring it with you.

FDA MedWatch- Boston Scientific NexStent Monorail-Class I Recall Because The Tip Of The Stent May Detach From The Delivery System During Carotid Artery Stenting Procedures

Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#NexStent

FDA MedWatch - Byetta (exenatide) - Reports of 6 cases of hemorrhagic or necrotizing pancreatitis since October 2007

Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis. Read the complete MedWatch 2008 Safety Summary, including a link to the '"Information for Healthcare Professionals" page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta

FDA MedWatch-Tysabri (natalizumab)-Two New Cases Of Progressive Multifocal Leukoencephalopathy In European Patients Receiving Drug As Monotherapy For Multiple Sclerosis For More Than One Year

FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,5000 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years. In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Chron's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications. Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri2

FDA MedWatch- Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) - Report Of SEAS Trial Of A Possible Association Between The Use Of Vytorin And A Potential Increased Incidence Of Cancer

FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.

Read the complete MedWatch 2008 Safety Summary, including a link to the '"Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin); Simvastatin (marketed as Zocor); and Ezetimibe (marketed as Zetia)", at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2

FDA MedWatch -Vivitrol (naltrexone)- Serious Injection Site Reactions May Occur

FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

Read the entire MedWatch Safety Summary, including a link to the FDA Drug Information Page regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone

FDA MedWatch - Simvastatin Used With Amiodarone - Risk of rhabdomyolysis when simvastatin is used with amiodarone

FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

Read the complete MedWatch safety summary, including links to the FDA Drug Information page, Information for Healthcare Professionals sheet, and labels (Prescribing Information) for simvastatin and amiodarone products, at http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin

FDA MedWatch -The August 2008 FDA Patient Safety News Video is now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn

MedWatch - Levitronix CentriMag Extracorporeal Blood Pumping System: risk of pump stoppage with use of certain electrosurgery units

Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.
Read the complete MedWatch 2008 Safety summary, including links to the FDA recall notice and the Levitronix Dear Doctor letter, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#CentriMag

FDA MedWatch -Viapro 375mg Capsules- Voluntary Recall Because The Product Was Found To Contain A Potentially Harmful Analog Of Sildenafil

EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.
Read the entire 2008 MedWatch Safety summary, including a link to the manufacturer's Press Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Viapro

FDA MedWatch- Erythropoiesis Stimulating Agents: Procrit, Epogen, and Aranesp- FDA Clarifies Approved Conditions For Use Of ESAs In Patients With Cancer And Revises Dosing Directions

Amgen and FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Follow Up to an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2

MedWatch - Mitoxantone (marketed as Novantrone and generics): updated cardiotoxicity warnings/recommendations
FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug. These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.

Read the complete MedWatch 2008 Safety summary, including links to the Information for Healthcare Professionals sheet and the previous 2005 safety alert, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone

MedWatch - Abacavir/Ziagen: Association between HLA allele and severe hypersensitivity reactions identified

FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
Read the complete MedWatch 2008 Safety Summary, including a link to the Information for Healthcare Professionals document, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Abacavir

MedWatch - Micro-bubble Contrast Agents (Definity, Optison): changes to Boxed Warnings, Warnings and Contraindications

FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

These changes reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.

Read the complete MedWatch 2008 safety summary, including links to the Information for Healthcare Professionals and previous MedWatch alerts, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Microbubble

FDA MedWatch -Electronic Medical Devices- Possible Malfunction Caused By Computed Tomography (CT) Scanning

FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical

FDA MedWatch- MedWatch-Sodium Polystyrene Sulfonate Suspension-Recall Of 2 Lots Of Product Due To The Presence Of Yeast Which Could Affect Immunocompromised Patients

Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.

See the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#SPSS

Governor Crist issues Executive Order 08-170 regarding Emergency Management for Tropical Storm Fay

On Saturday, August 16, 2008, Governor Crist issued Executive Order 08-170, declaring a state of emergency for the entire State of Florida due to the threat that Tropical Storm Fay imposes to the state

Section 4, paragraph D, of the executive order authorizes pharmacists in areas or counties covered under this executive order to dispense up to a 30-day emergency prescription refill in accordance with section 465.0275, Florida Statutes.

Further, section 8, of the executive order provides that medical professionals and workers, social workers, and counselors with good and valid professional licenses issued by states other than the State of Florida may render such services in Florida during this emergency for persons affected by this emergency with the condition that such services be rendered to such persons free of charge, and with the further condition that such services be rendered under the auspices of the America Red Cross or the Florida Department of Health.

Additionally, please note that section 252.358, Florida Statutes, requires that all health insurers, managed care organizations, and other entities that are licensed by the Office of Insurance Regulation and provide prescription medication coverage as part of a policy or contract waive time restrictions on prescription medication refills, which include suspension of electronic "refill too soon" edits to pharmacies, to enable insureds or subscribers to refill prescriptions in advance, if there are authorized refills remaining, and shall authorize payment to pharmacies for at least a 30-day supply of any prescription medication, regardless of the date upon which the prescription had most recently been filled by a pharmacist, when the following conditions occur: The person seeking the prescription medication refill resides in a county that is under a hurricane warning issued by the National Weather Service, is declared to be under a state of emergency in an executive order issued by the Governor, or has activated its emergency operations center and its emergency management plan.

DOH PRESS RELEASE: Medications in Disaster Situations (pdf - 24kb)

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

Actavis Totwa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey Facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The inspection at Little Falls revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.

This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. If patients should wish to obtain replacement medications and/or prescription, they should contact their health care professional or pharmacist. For more information regarding this market action, please visit http://www.actavis.us/en/media+center/newsroom/articles/recallFAQ.htm.

Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI.

Actavis Totowa, LLC is a United States subsidiary of Actavis Group hf. The voluntary action is limited only to Actavis Totowa products manufactured in the Little Falls, NJ facility listed below. Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other facilities are thus not impacted by this recall.

The recalled products manufactured by the Little Falls facility are:

North Carolina Board of Pharmacy to allow Florida Pharmacists to Reciprocate (pdf - 9kb)

SureScripts, RxHub Merge to Expand e-Prescribing Network
SureScripts and RxHub, the two largest networks for electronic prescription transactions in the United States, merged on June 30, 2008. The consolidation of both operations will form a single secure national network for the exchange of prescription related data among physicians, pharmacies, and prescription benefit management organizations. Both organizations were launched in 2001. RxHub was founded by three large prescription benefits management organizations, including CVS Caremark, Medco Health Solutions, and Express Scripts. SureScripts was formed by the National Association of Chain of Drug Stores and the National Community of Pharmacists Association. RxHub’s expertise in patient identification and delivering drug benefit information to the physician at the point of care complements SureScripts’ focus on electronic prescription routing from the physician’s office to the pharmacy. The merger combines these strengths with a shared focus on more access to patient medication history, enabling physicians to access patient health information and transmit e-prescriptions and renewal requests to pharmacies. More information is available at www.surescriptsrxhub.com.

FDA Takes Action Against Companies Marketing Unapproved Injectable Colchicine
Food and Drug Administration (FDA) is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine tablets are not affected by FDA's action at this time. The injectable form of colchicine is especially hazardous because the therapeutic index is very narrow. Adding to the problem, certain side effects that might alert the clinician that the dose is too high do not appear until the patient has already reached toxic levels. Because of its toxicity and the availability of safer therapies, injectable colchicine is rarely used to treat gout anymore, but some practitioners prescribe it to treat back pain. FDA states that the risks of this treatment outweigh the benefits. FDA also cautions pharmacies against compounding injectable colchicine products. Because of the drug’s toxicity and narrow therapeutic index, any errors that occur during compounding can have potentially fatal consequences. More information is available in the FDA MedWatch Safety Alert at www.fda.gov/medwatch/safety/2008/safety08.htm#colchicine.

FDA MedWatch- Avastin (bevacizumab) and sunitinib malate- Reports of Microangiopathic Hemolytic Anemia In Patients Treated With This Combination
Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Provider Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avastin

FDA MedWatch - The July 2008 FDA Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn.

FDA MedWatch- Recombinant Human Bone Morphogenetic Protein: Reports Of Life-threatening Complications In Cervical Spine Fusion
FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

Read the entire 2008 MedWatch Safety Summary, including the FDA's Public Health Notification regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein

FDA MedWatch -Rize 2 The Occasion Capsules And Rose 4 Her Capsules- Products Recalled Because They Contain An Undeclared Ingredient
Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. The products were recalled because certain lots contained thiomethisosildenafil, an undeclared ingredient that is an analog of sildenafil, a FDA-approved drug used for Erectile Dysfunction. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking the products. See the manufacturer's press release for the specific lot numbers of the recalled products.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this recall at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rize

MedWatch - Fluoroquinolones: Boxed Warning to be added for risk of tendon rupture and tendonitis
FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

This risk of tendinitis and tendon rupture is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

FDA Medwatch - Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients.

Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vials, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the event a compromised vial is discovered.

FDA MedWatch - 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product recalled: bacteria contamination
Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.

FDA MedWatch- CellCept (mycophenolate mofetil)-Reports Of Progressive Multifocal Leukoencephalopathy In Patients Treated With CellCept
Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept.

Switch to HFA-Propelled Albuterol Inhalers Advised in Anticipation of CFC Ban
Food and Drug Administration (FDA) recently issued a public health advisory alerting patients, caregivers, and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after 2008. CFC-propelled albuterol inhalers are being phased out to comply with the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the US has agreed to phase out production and importation of ozone-depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed, or sold in the US after December 31. Three HFA-propelled albuterol inhalers have been approved by FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol is available as Xopenex HFA Inhalation Aerosol. More information is available on the FDA Web site at http://www.fda.gov/cder/mdi/albuterol.htm

Governor Charlie Crist signed SB 1360 (pdf) into law on June 23, 2008.  This law becomes effective immediately upon becoming law unless otherwise provided in the bill language. 

The bill, upon becoming law, removes the requirement that an applicant for pharmacist licensure by endorsement must have passed the licensure examination of the National Association of Boards of Pharmacy (NABP) or a similar nationally recognized exam within the last twelve years in order to qualify for licensure by this method.
Additionally, the bill requires the Board of Pharmacy to begin registering pharmacy technicians as of January 1, 2010.

Board of Pharmacy Legislative Update as of 6/17/08 (pdf - 607kb)

Governor Charlie Crist signed HB 7049 (pdf - 4mb) (2008) into law on June 17, 2008. This law becomes effective on July 1, 2008 unless otherwise provided in the bill language.

FDA MedWatxh Spring 2008 Issue of The FDA Safety Newsletter (pdf)

U.S. Drug Enforcement Administration (DEA) Pamphlet: Combat Methamphetamine Act of 2005 (CMEA): Preventing the retail Diversion of Pseudoephdrine (pdf)

FDA MedWatch- Antipsychotics Associated With An Increased Risk Of Mortality In Elderly Patients Treated For Dementia-Related Psychosis
FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNING section.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics

FDA MedWatch - Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness
ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

FDA MedWatch: Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

FDA MedWatch - The June 2008 FDA Patient Safety News is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

FDA MedWatch -Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder- Product Recalled Because Of Oxidation
Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Calcilo

FDA Public Health Advisory: National Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers

FDA is alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers. As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now.

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with obstructive airways disease, such as asthma and chronic obstructive pulmonary disease (COPD). The propellants (spray), CFC and HFA, push the albuterol into the lungs when a patient inhales. Currently there are three approved HFA propelled albuterol inhalers: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol. Each of the above four HFA propelled inhalers is a safe and effective replacement for CFC propelled albuterol inhalers. The manufacturers of HFA inhalers have increased production so that there is adequate supply of these products available now.

HFA propelled albuterol inhalers may taste and feel different than the CFC propelled albuterol inhalers. Notably, the force of the spray of an HFA propelled inhaler may feel softer than that of a CFC propelled inhaler. It is important to prime and clean the HFA propelled inhalers to prevent blockage in the inhaler device that will prevent the medicine from reaching the lungs. Each HFA propelled inhaler has different priming, cleaning, and drying instructions. Therefore, it is important to read and understand the instructions that come with each of the HFA propelled albuterol inhalers before using.

The national transition from CFC propelled to HFA propelled albuterol inhalers is due to an international environmental treaty called the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS) including CFCs. Several CFC propelled inhalers containing other medicines have already been phased out. Over the next several years, other CFC propelled inhalers will be phased out. You can find more information at http://www.fda.gov/cder/mdi/albuterol.htm.

FDA MedWatch-Viril-ity Power (VIP) Tablets: Recall Of Supplement Product Because It Contains A Potentially Harmful Undeclared Ingredient
International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs ( such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#VIP

FDA MedWatch- Xiadafil VIP Tablets- Product Contains Potentially Harmful, Undeclared Ingredient That May Cause Life-Threatening Side Effects
FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.
Read the entire 2008 MedWatch Safety Summary, including a link to the Agency's News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Xiadaf

Trasylol (aprotinin injection) to be removed from all hospital pharmacies, available only under limited use agreement access
Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
 
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
Read the complete MedWatch safety summary, including links to the updated drug information page and the FDA news statement, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol

Drug Recall: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution

Contact: Stericycle customer service 1-888-276-6166

FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.

The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch/.

FDA MedWatch - The May 2008 FDA Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn.
Effective April 15, 2008, Levothyroxine Sodium has been removed from the Negative Drug Formulary.  Click Here to review the letter sent to Pharmacy Department Managers. (pdf - 189kb)

FDA MedWatch- Enbrel (etanercept)-Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis
Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:  http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel

MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on web - The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm 

The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm 

FDA MedWatch- Herbal Science International, Inc. Recalls Dietary Herbal Supplements Because They May Present A Serious Health Hazard To Consumers
Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that c