FDA MedWatch

FDA requires new Boxed Warnings and patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms

FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx. Hi-Tech was notified by the FDA that the lab analysis of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 inhibitor.

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). 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.

FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients.

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.

FDA provides 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 in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.

Patients advised to check personal supply of insulin to identify possible stolen and dangerous product.

FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton.

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.

Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components.