http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm
FDA Posts List of Drugs Being Investigated for Safety Issues
The Food and Drug Administration posted a list of 20 drugs to its website Friday that are being evaluated for potential safety issues. The agency plans to post a quarterly list—in compliance with a requirement of the Food and Drug Administration Amendments Act, which was signed into law in September 2007—of medications being investigated for such problems. Despite the agency's concerns, patients shouldn't stop taking medications on the list without first talking to their doctors, the FDA advises. Among the drugs included on the list are Oxycontin (concerns: potential misuse, abuse, and overdose), tumor necrosis factor (TNF) blockers (cancers in young adults and children), Cymbalta (urinary retention), and Heparin (anaphylactic-type reactions).
Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008
Product Name: Active Ingredient (Trade)
or Product Class Potential Signal of Serious Risk/New Safety Information
Arginine Hydrochloride Injection (R-Gene 10) Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane) Cardiac arrest
Duloxetine (Cymbalta) Urinary retention
Etravirine (Intelence) Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusion
Heparin Anaphylactic-type reactions
Icodextrin (Extraneal) Hypoglycemia
Insulin U-500 (Humulin R) Dosing confusion
Ivermectin (Stromectol) and Warfarin Drug interaction
Lapatinib (Tykerb) Hepatotoxicity
Lenalidomide (Revlimid) Stevens Johnson Syndrome
Natalizumab (Tysabri) Skin melanomas
Nitroglycerin (Nitrostat) Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin) Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity) Cardiopulmonary reactions
Phenytoin Injection (Dilantin) Purple Glove Syndrome
Quetiapine (Seroquel) Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka) Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults