For the first time, the Food and Drug Administration is issuing a quarterly report of drugs that are being investigated for possible serious side effects.
Last year, Congress passed and the president signed into law a bill that required the FDA to start telling the public when it has started to investigate drugs, even at the earliest stages. Before this law went into effect, the FDA would have been investigating these drugs in secret. FDA officials caution these are all possible risks and may ultimately prove to have nothing at all to do with the drug.
Here are the drugs currently under investigation:
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
Tebivudine (Tyzeka) - Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers - Cancers in children and young adults
