Profession Updates

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FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

NEW! DEA announces that on Tuesday, October 28, 2008, an updated electronic version of the DEA form 106 will be available through the Diversion website

This newer version requires the registrant to include the National Drug Code (NDC) which will help to accurately track controlled substances reported as stolen or lost.

The attached letter will be posted on the Diversion website advising all DEA registrants of this change in reporting requirements. DEA will notify any registrant that submits a paper copy of the obsolete DEA form 106 after October 28, 2008, to discontinue using this form. DEA advises registrants wishing to obtain an electronic copy of the new DEA form 106 to go DEA's website and select the icon "DEA Form 106 Online, Report Theft or Loss of Controlled Substances."

Although the paper version is still available, DEA encourages registrants to use the updated electronic version. A registrant can still receive a paper copy of the updated form by writing to DEA Headquarters, Attn: Registration/ODR, P.O. Box 2639, Springfield, VA 22152. PLEASE NOTE: The correct phone number for the DEA Registration & Program Support Section is: (202) 307-4925. The letter on the DEA website will be corrected to reflect this as well.

NEW! Destruction and Disposal of Prescription Drugs
Below are links to external websites which contain guidance on how to destroy or dispose of controlled substances.

• Florida Department of Environmental Protection: How to Dispose of Unwanted Medications
• Office of National Drug Control Policy: Proper Disposal of Prescription Drugs
• U.S. Food and Drug Administration: How to Dispose of Unused Medications
• U.S. Drug Enforcement Administration: Pharmacist’s Manual (Sees page 12-14)

These Website links are provided for informational purposes only. The Board has not screened the information that appears on these sites or that is electronically linked to these sites. The Board disclaims any and all warranties with regard to the Website and Website information.

NEW! 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

NEW! 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

NEW! 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

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

NEW! Methamphetamine Production Prevention Act of 2008 Signed into Law

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

NEW! 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.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate

NEW! 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

NEW! 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

NEW! 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

NEW! 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

NEW! 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.

NEW! 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.

NEW! 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.

NEW! The Florida Department Of Health Recognizes October As American Pharmacists Month (pdf - 27kb)

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

NEW! 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.

NEW! 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.

NEW! 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. 

NEW! 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.

NEW! 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.

NEW! 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.

NEW! 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.

NEW! FDA MedWatch - Phosphocol P 32- Risk Of Leukemia Associated With Off-Label 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.!

NEW! 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.

NEW! 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

NEW! 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.

NEW! 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.

NEW! 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.

NEW! 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.

NEW! 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.

NEW! 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

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

NEW! 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.

NEW! 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

NEW! 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

NEW! 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.

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

NEW! 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

NEW! 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

NEW! 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

NEW! 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.

NEW! 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.

NEW! 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

NEW! 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.

NEW! 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.

NEW!  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.

NEW! 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.

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:

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