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