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FDA MedWatch Alerts

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July 1, 2009
Audience: Neuropsychiatric healthcare professionals, patients. FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add...
July 1, 2009
Audience: Diabetes healthcare professionals, patients. FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for...
June 20, 2009
Audience: Consumers, All Healthcare Professionals. 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...
June 19, 2009
Audience: Consumers. FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient -...
June 17, 2009
Audience: Infectious disease healthcare professionals. 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...
June 16, 2009
Audience: Consumers. 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...
June 15, 2009
Audience: Cardiology healthcare professionals. [Posted 06/11/2009] 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...
June 15, 2009
Audience: Pediatricians, Neuropsychiatric healthcare professionals. Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse...
June 13, 2009
Audience: Patients, pharmacists, diabetes healthcare professionals. 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...
June 12, 2009
Audience: Pulmonology healthcare professionals. FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communication about the ongoing safety review for the...
June 11, 2009
Audience: Transplantation healthcare professionals. 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...
June 9, 2009
Audience: Consumers, pharmacists, all healthcare professionals. FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of...
June 3, 2009
Audience: Endocrine healthcare professionals, Pharmacists, Pediatricians. FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and pediatric patients....
May 30, 2009
Audience: Rheumatological healthcare professionals [Posted 05/27/2009] Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-α blockers, including Simponi...
May 29, 2009
Audience: Pharmacists, cardiology healthcare professionals, consumers [UPDATED 05/12/2009] AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31,...
May 28, 2009
Audience: Urological and Endocrinological healthcare professionals, pediatricians  [Posted 05/07/2009] FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to...
May 28, 2009
Audience: Emergency care managers, hospital risk managers, laboratory services managers [Posted 05/08/2009] Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health...
May 28, 2009
Audience: Oncological, dermatological and ophthalmological healthcare professionals  [Posted 05/08/2009] OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the...
May 28, 2009
Audience: Consumers, Pediatricians, Dermatologists [UPDATED 05/26/2009] 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) The products were...
May 28, 2009
Audience: Rheumatological healthcare professionals. Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-α blockers, including Simponi [golimumab]. FDA has reported that...
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