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:
1. Arginine Hydrochloride Injection (R-Gene 10) — Pediatric overdose due to labeling and packaging confusion
2. Desflurane (Suprane) — Cardiac arrest
3. Duloxetine (Cymbalta) — Urinary retention
4. Etravirine (Intelence) — Hemarthrosis (blood in a joint)
5. Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) — Adverse events due to name confusion
6. Heparin — Anaphylactic-type (life-threatening allergic) reactions
7. Icodextrin (Extraneal) — Hypoglycemia (low blood sugar)
8. Insulin U-500 (Humulin R) — Dosing confusion
9. Ivermectin (Stromectol) and Warfarin — Drug interaction
10. Lapatinib (Tykerb) — Hepatotoxicity (liver toxicity)
11. Lenalidomide (Revlimid) — Stevens-Johnson syndrome (a deadly drug reaction)
12. Natalizumab (Tysabri) — Skin melanomas (deadly skin cancer)
13. Nitroglycerin (Nitrostat) — Overdose due to labeling confusion
14. Octreotide Acetate Depot (Sandostatin LAR) — Ileus (bowels not moving)
15. Oxycodone Hydrochloride Controlled-Release (OxyContin) — Drug misuse, abuse, and overdose
16. Perflutren Lipid Microsphere (Definity) — Cardiopulmonary reactions (lung/heart problems)
17. Phenytoin Injection (Dilantin) — Purple glove syndrome (discoloration, pain, and swelling of the hand that may lead to amputation)
18. Quetiapine (Seroquel) — Overdose due to sample pack labeling confusion
19. Tebivudine (Tyzeka) — Peripheral neuropathy (tingling or numbness in the extremities)
20. Tumor Necrosis Factor (TNF) Blockers — Cancers in children and young adults
Source: FDA September 5, 2008
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