FDA MedWatch – Nestle Toll House Prepackaged, Refrigerated Cookie Dough

FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died. E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death.

FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Individuals who have recently eaten prepackaged, refrigerated Toll House cookie dough and have experienced any of these symptoms should contact their doctor or health care provider immediately. Any such illnesses should be reported to state or local health authorities.

CLICK HERE to read the complete MedWatch 2009 Safety summary including links to the FDA news release and consumer update and the CDC information page.

FDA MedWatch – Stamina-Rx Dietary Supplement Products

FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction. Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in the! ir possession should stop using it immediately.

CLICK HERE to read the complete MedWatch Safety summary, including a link to the firm press release.

FDA MedWatch – Cefepime (marketed as Maxipime)

FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analys! es likely will be reported in approximately one year.

CLICK HERE to read the complete MedWatch 2009 Safety Summary, including links to the Update of Ongoing Safety Review and previous 2007 and 2008 MedWatch safety alerts.

Dr. Todd Rice Named Medical Director of IRB

Todd Rice, M.D., M.Sc., has recently been appointed as the medical director of Vanderbilt’s IRB. Dr. Rice has served as a voting member, Vice-Chair, and Chair of the Health Sciences 2 committee over the past few years. In addition, he is an assistant professor and serves within the Division of Allergy, Pulmonary, and Critical Care Medicine.

FDA MedWatch – Zicam Cold Remedy Nasal Products

FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

CLICK HERE to read the complete MedWatch 2009 Safety Summary, including links to the Public Health Advisory and Consumer Update page.

FDA MedWatch – Stimulant Medications Use in Children with AD/HD

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this stu! dy should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

CLICK HERE to read the complete MedWatch 2009 Safety Summary, including a link to the Communication and the FDA News Release.

FDA MedWatch – Levemir Insulin (Novo Nordisk)

FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:

• Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038.
• Do not use your Levemir insulin if it is from one of these lots.
• Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
• Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.

CLICK HERE to read the complete MedWatch 2009 Safety Summary, including a link to the FDA News Release.

(Updated) Did you know…

that the Food and Drug Administration (FDA) recently issued a final rule that requires institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS)? While the FDA’s requirement may be new, Vanderbilt’s IRBs have already been registered with HHS for quite a while in accordance with our Federalwide Assurance (FWA). If your sponsor is asking you if your IRB is registered, please direct them to THIS LINK and have them search for “Vanderbilt.”

FDA MedWatch – Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers

Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer. To determine if a pacemaker is part of this recall, contact Medtronic at 1-800-505-4636.

CLICK HERE to read the complete MedWatch 2009 Safety Summary, including links to the FDA news release, recall notice and consumer information.

FDA MedWatch – Sirolimus (marketed as Rapamune)

FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the FDA Healthcare Professional Information Sheet