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Latest Medical Device News

• Antiepileptic Drugs
• Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
• Biosite brand Triage Cardiac Panel - Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis.
• Cefepime (marketed as Maxipime) Update of Ongoing Safety Review - 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.
• Fun Express Water-based Face Paints for Children - UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint)
• Lantus (insulin glargine) - FDA reviewing safety data regarding possible risk for cancer in patient with diabetes.
• Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) - 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. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
• Levemir Insulin (Novo Nordisk) - Patients advised to check personal supply of insulin to identify possible stolen and dangerous product.
• Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers - 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.
• 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). 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. 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.
• Propylthiouracil - Propylthiouracil (PTU)-Induced Liver Failure
• Simponi (golimumab) - Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009
• 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.
• Skin Products Made by Clarcon - FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse.
• Stamina-Rx Dietary Supplement Products - 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.
• Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review - 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.
• Tarceva (erlotinib) May 2009 - Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration.
• Testosterone gel products (AndroGel 1% and Testim 1% ) - Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone.
• Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) - FDA requires new Boxed Warnings and patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms
• Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) - 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 these 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

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