Drugs.com - FDA MedWatch Alerts

Innohep (tinzaparin sodium injection)

Wed, 31 Dec 2008 05:00:00 GMT

Audience: Hematological and Nephrological healthcare professionals, hospital risk managers [UPDATE 12/31/2008] Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the...

Hydromorphone HCl 2 mg Tablets

Wed, 24 Dec 2008 05:00:00 GMT

Audience: Pharmacists, consumers, primary care healthcare professionals [Posted 12/24/2008] ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized...

Weight Loss Pills

Mon, 22 Dec 2008 05:00:00 GMT

Audience: Consumers, primary care healthcare professionals [Posted 12/22/2008] FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active...

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)

Thu, 11 Dec 2008 05:00:00 GMT

Audience: All healthcare professionals, consumers[Posted 12/11/2008] FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing...

Healon D Ophthalmic Viscosurgical Device

Thu, 11 Dec 2008 05:00:00 GMT

Audience: Ophthalmologic healthcare professionals [Posted 12/11/2008] Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a recall of Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size...

20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

Tue, 09 Dec 2008 05:00:00 GMT

Audience: Hospital pharmacists, hospital risk managers, other healthcare professionals [Posted 12/09/2008] Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09)...

Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae

Mon, 08 Dec 2008 05:00:00 GMT

Audience: Cardiological healthcare professionals, hospital risk managers [Posted 12/08/2008] Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes...

Innohep (tinzaparin sodium injection)

Tue, 02 Dec 2008 05:00:00 GMT

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...

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Tue, 02 Dec 2008 05:00:00 GMT

Audience: Oncologists, other healthcare professionals[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs....

Starcaps Dietary Supplement Capsules

Wed, 26 Nov 2008 05:00:00 GMT

Audience: Consumers, healthcare professionals [Posted 11/26/2008] Balanced Health Products, Inc. announced a recall of STARCAPS due to the presence of an undeclared drug ingredient, Bumetanide. Bumetanide is a diuretic indicated for the treatment of...

Zhen De Shou Fat Loss Capsules

Wed, 26 Nov 2008 05:00:00 GMT

Audience: Consumers, healthcare professionals [Posted 11/26/2008] Fashion Sanctuary announced a recall of Zhen De Shou Fat Loss Capsules because FDA analysis found the product to contain undeclared sibutramine, an FDA approved drug used as an...

Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)

Mon, 24 Nov 2008 05:00:00 GMT

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)...

Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump

Thu, 20 Nov 2008 05:00:00 GMT

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...

Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel

Mon, 17 Nov 2008 05:00:00 GMT

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...

Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)

Wed, 12 Nov 2008 05:00:00 GMT

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...

Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa)

Wed, 12 Nov 2008 05:00:00 GMT

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...

Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg)

Mon, 10 Nov 2008 05:00:00 GMT

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...

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

Thu, 06 Nov 2008 05:00:00 GMT

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...

Raptiva (efalizumab)

Fri, 17 Oct 2008 04:00:00 GMT

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...

Dextroamphetamine Sulfate 5mg Tablets

Thu, 16 Oct 2008 04:00:00 GMT

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...

Over The Counter Cough and Cold Medications

Thu, 09 Oct 2008 04:00:00 GMT

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...

Tiotropium (marketed as Spiriva HandiHaler)

Tue, 07 Oct 2008 04:00:00 GMT

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...

Nebion HLX-8 Magnetic Resonance Device

Fri, 03 Oct 2008 04:00:00 GMT

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...

Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit

Thu, 02 Oct 2008 04:00:00 GMT

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...

Statin drugs and amyotrophic lateral sclerosis (ALS)

Tue, 30 Sep 2008 04:00:00 GMT

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...

Epoetin alfa

Fri, 26 Sep 2008 04:00:00 GMT

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...

Tarceva (erlotinib)

Tue, 23 Sep 2008 04:00:00 GMT

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,...

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%

Tue, 23 Sep 2008 04:00:00 GMT

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...

Infant Formula Manufactured in China Contaminated With Melamine

Mon, 22 Sep 2008 04:00:00 GMT

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...

Phosphocol P 32 (Chromic Phosphate P 32 Suspension)

Thu, 18 Sep 2008 04:00:00 GMT

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...

LifePak CR Plus Automated External Defibrillators

Tue, 16 Sep 2008 04:00:00 GMT

Audience: Emergency medical personnel, other healthcare professionals [Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in...

Infant Formula Manufactured in China

Fri, 12 Sep 2008 04:00:00 GMT

Audience: Consumers, pediatricians, other healthcare professionals [Posted 09/12/2008] FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese...

Rituxan (rituximab)

Thu, 11 Sep 2008 04:00:00 GMT

Audience: Oncologists, rheumatologists, other healthcare professionals, consumers[Posted 09/11/2008] Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal...

LifePak CR Plus Automated External Defibrillators

Thu, 11 Sep 2008 04:00:00 GMT

Disposable Battery Operated Lavage System (BOLS)

Mon, 08 Sep 2008 04:00:00 GMT

Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers [Posted 09/08/2008] FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable...

Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)

Thu, 04 Sep 2008 04:00:00 GMT

Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other...

Pacific Consolidated brand Mobile Oxygen Storage Tank

Mon, 01 Sep 2008 04:00:00 GMT

Audience: Emergency healthcare professionals, military emergency/disaster/field hospital/aviation personnel [Posted 08/28/2008] Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile...

Tysabri (natalizumab)

Mon, 25 Aug 2008 04:00:00 GMT

Audience: Neurologists, other healthcare professionals, patients[Posted 08/25/2008] FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for...

Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)

Thu, 21 Aug 2008 04:00:00 GMT

Audience: Endocrinologists, cardiologists, other healthcare professionals, patients[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial...

Byetta (exenatide)

Mon, 18 Aug 2008 04:00:00 GMT

Audience: Endocrinologists, other healthcare professionals, consumers[UPDATED 08/18/2008] Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in...