Drugs.com - FDA MedWatch Alerts

Propoxyphene-containing Products

Tue, 07 Jul 2009 04:00:00 GMT

Audience: Pharmacists, pain management healthcare professionals FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data...

Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)

Wed, 01 Jul 2009 04:00:00 GMT

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...

Lantus (insulin glargine)

Wed, 01 Jul 2009 04:00:00 GMT

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...

Nestle Toll House Prepackaged, Refrigerated Cookie Dough

Sat, 20 Jun 2009 04:00:00 GMT

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...

Stamina-Rx Dietary Supplement Products

Fri, 19 Jun 2009 04:00:00 GMT

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 -...

Cefepime (marketed as Maxipime) Update of Ongoing Safety Review

Wed, 17 Jun 2009 04:00:00 GMT

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...

Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)

Tue, 16 Jun 2009 04:00:00 GMT

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...

Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers

Mon, 15 Jun 2009 04:00:00 GMT

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 of...

Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review

Mon, 15 Jun 2009 04:00:00 GMT

Audience: Pediatricians, Neuropsychiatric healthcare professionals Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse...

Levemir Insulin (Novo Nordisk)

Sat, 13 Jun 2009 04:00:00 GMT

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...

Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

Fri, 12 Jun 2009 04:00:00 GMT

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 leukotriene...

Sirolimus (marketed as Rapamune)

Thu, 11 Jun 2009 04:00:00 GMT

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...

Skin Products Made by Clarcon

Tue, 09 Jun 2009 04:00:00 GMT

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...

Propylthiouracil

Wed, 03 Jun 2009 04:00:00 GMT

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....

Simponi (golimumab)

Sat, 30 May 2009 04:00:00 GMT

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-Î± blockers, including Simponi...

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Fri, 29 May 2009 04:00:00 GMT

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,...

Testosterone gel products (AndroGel 1% and Testim 1% )

Thu, 28 May 2009 04:00:00 GMT

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...

Biosite brand Triage Cardiac Panel

Thu, 28 May 2009 04:00:00 GMT

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...

Tarceva (erlotinib) May 2009

Thu, 28 May 2009 04:00:00 GMT

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...

Fun Express Water-based Face Paints for Children

Thu, 28 May 2009 04:00:00 GMT

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...

Simponi (golimumab)

Thu, 28 May 2009 04:00:00 GMT

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...

Fun Express Water-based Face Paints for Children

Tue, 26 May 2009 04:00:00 GMT

Audience: Consumers, Pediatricians, Dermatologists 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 distributed primarily to...

Antiepileptic Drugs

Mon, 18 May 2009 04:00:00 GMT

Audience: Neuropsychiatric healthcare professionals, other healthcare professionals, patients [UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric...

Fun Express Water-based Face Paints for Children

Tue, 12 May 2009 04:00:00 GMT

Audience: Consumers, Pediatricians, Dermatologists FDA is notifying consumers and healthcare professionals of the recall of cosmetic "Face Paint" items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event...

Digoxin, USP 0.25 mg

Tue, 12 May 2009 04:00:00 GMT

Audience: Pharmacists, cardiology healthcare professionals, consumers 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, 2009, which are not...

Influend Cough and Cold Products

Mon, 11 May 2009 04:00:00 GMT

Audience: Pharmacists, consumers [Posted 04/16/2009] ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be...

Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.

Mon, 11 May 2009 04:00:00 GMT

Audience: Consumers, pharmacists [Posted 04/22/2009] ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug,...

Tarceva (erlotinib)

Fri, 08 May 2009 04:00:00 GMT

Audience: Oncological, dermatological and ophthalmological healthcare professionals OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for...

Testosterone gel products (AndroGel and Testim)

Thu, 07 May 2009 04:00:00 GMT

Audience: Urological and Endocrinological healthcare professionals, pediatricians FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on...

Antiepileptic Drugs

Tue, 05 May 2009 04:00:00 GMT

Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Fri, 01 May 2009 04:00:00 GMT

Audience: Diabetes healthcare professionals, patients Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the "up" and/or "down" buttons of some ACCU-CHEK Spirit insulin pumps. This failure...

Hydroxycut Products

Fri, 01 May 2009 04:00:00 GMT

Audience: Consumers, healthcare professionals FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc., because they are associated with serious liver injuries. Hydroxycut products are dietary supplements...

Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

Thu, 30 Apr 2009 04:00:00 GMT

Audience: Cosmetic surgeons, neurologists, consumers FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen...

Personal Care Non-Acetone Nail Polish Remover

Wed, 29 Apr 2009 04:00:00 GMT

Audience: Dermatologists, ER healthcare professionals Personal Care Products and FDA notified healthcare professionals of a voluntary nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin,...

Libimax

Wed, 29 Apr 2009 04:00:00 GMT

Audience: Consumers, pharmacists Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for...

Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.

Wed, 22 Apr 2009 04:00:00 GMT

Influend Cough and Cold Products

Thu, 16 Apr 2009 04:00:00 GMT

Ceftriaxone (marketed as Rocephin and generics)

Tue, 14 Apr 2009 04:00:00 GMT

Audience: Neonatology, infectious disease healthcare professionals, hospital risk managers [Posted 04/14/2009] FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with...

Raptiva (efalizumab)

Wed, 08 Apr 2009 04:00:00 GMT

Audience: Dermatological healthcare professionals, patients [UPDATE 04/08/2009] Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to...

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Wed, 01 Apr 2009 04:00:00 GMT

Audience: Pharmacists, cardiology healthcare professionals, consumers [Posted 04/01/2009] Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin,...