FDA Lists Drugs Under Investigation For Safety Concerns

The FDA has issued its first public disclosure of 20 drugs it is now investigating for safety concerns. The disclosure is the result of the 2007 Food and Drug Administration Amendments Act that mandated that the agency post on a quarterly basis information about drugs it is investigating based on adverse events reported by doctors. The information does not disclose the nature of the adverse events or the extent of the problem. The fact that a drug is listed is not intended to suggest that the agency has, in fact, concluded that the risk exists. The posting does not include all of the drugs currently being subjected to a further safety investigation.

The consumer now has more information at hand to make an informed decision about drugs a doctor prescribes. Hopefully, these disclosures will prevent unnecessary injury when the FDA and the manufacturer are aware of potential risks, and the unsuspecting patient is not. That is a gap that should, and must, be closed. Here is the list:

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
Telbivudine (Tyzeka): Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers: Cancers in children and young adults

Sources:

FDA FAQs

FDA’s Report, January to March, 2008