FDA MedWatch Alerts
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December 2, 2008
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
[Posted 12/02/2008] FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by...
November 24, 2008
Audience: Neurological healthcare professionals[Posted 11/24/2008] FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)...
November 20, 2008
Audience: Consumers, endocrinological healthcare professionals
[Posted 11/20/2008] Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020...
November 17, 2008
Audience: Consumers, dermatologists, pharmacists, other healthcare professionals[Posted 11/17/2008] CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne...
November 12, 2008
Audience: Consumers, pediatricians, other healthcare professionals[Posted 11/12/2008] Johnson & Johnson, Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas...
November 12, 2008
Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals[Posted 11/12/2008] FDA issued an update to the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients...
November 10, 2008
Audience: Pharmacists, other healthcare professionals, patients
[Posted 11/10/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release...
November 6, 2008
Audience: Patients with insulin-dependent diabetes; pharmacists[Posted 11/06/2008] Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed...
October 17, 2008
Audience: Dermatological healthcare professionals, patients[Posted 10/17/2008] FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial...
October 16, 2008
Audience: Pharmacists, other healthcare professionals, patients[Posted 10/16/2008] 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...
October 9, 2008
Audience: Pediatric and primary healthcare professionals, consumers
[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for...
October 7, 2008
Audience: Pulmonary care health professionals and patients[UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a...
October 3, 2008
Audience: Healthcare professionals, consumers
[Posted 10/03/2008] 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...
October 2, 2008
Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers
[Posted 10/02/2008] Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic...
September 30, 2008
Audience: Neurologists, cardiologists, consumers[Posted 09/30/2008] 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...
September 26, 2008
Audience: Neurological healthcare professionalsPosted 09/23/2008] 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...
September 23, 2008
Audience: Oncological healthcare professionals[Posted 09/23/2008] OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva,...
September 23, 2008
Audience: Hospital ER and ICU medical and nursing personnel, risk managersPosted 09/23/2008] Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may...
September 22, 2008
Audience: Consumers, pediatricians
[UPDATE 09/22/2008] FDA contacted companies who manufacture infant formula for distribution in the United States and has learned that they are not importing formula or source materials from China. FDA, in...
September 18, 2008
Audience: Oncologists, other healthcare professionals[Posted 09/18/2008] Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the...
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