FDA issues first "under investigation" list

WASHINGTON, D.C.; September 5, 2008

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

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