A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events. The first of this series of quarterly reports has been released. It includes adverse events reported between January 1 and March 31, 2008.
Here's the list of drugs and the adverse events that have been reported:
Arginine Hydrochloride Injection (R-Gene 10) -- Pediatric overdose due to labeling and packaging confusion
Desflurane (Suprane) -- Cardiac arrest
Duloxetine (Cymbalta) -- Urinary retention
Etravirine (Intelence) -- Hemarthrosis (blood in a joint)
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) -- Adverse events due to name confusion
Heparin -- Anaphylactic-type (life-threatening allergic) reactions
Icodextrin (Extraneal) -- Hypoglycemia (low blood sugar)
Insulin U-500 (Humulin R) -- Dosing confusion
Ivermectin (Stromectol) and Warfarin -- Drug interaction
Lapatinib (Tykerb) -- Hepatotoxicity (liver toxicity)
Lenalidomide (Revlimid) -- Stevens-Johnson syndrome (a deadly drug reaction)
Natalizumab (Tysabri) -- Skin melanomas (deadly skin cancer)
Nitroglycerin (Nitrostat) -- Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) -- Ileus (bowels not moving)
Oxycodone Hydrochloride Controlled-Release (OxyContin) -- Drug misuse, abuse, and overdose
Perflutren Lipid Microsphere (Definity) -- Cardiopulmonary reactions (lung/heart problems)
Phenytoin Injection (Dilantin) -- Purple glove syndrome (discoloration, pain, and swelling of the hand that may lead to amputation)
Quetiapine (Seroquel) -- Overdose due to sample pack labeling confusion
Tebivudine (Tyzeka) -- Peripheral neuropathy (tingling or numbness in the extremities)
Tumor Necrosis Factor (TNF) Blockers -- Cancers in children and young adults
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