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FDA: 20 Drugs under a Safety Probe

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.

Last week, the first posting of certain drugs happened. According to various sites, the quarterly list of prescription drugs shows those under investigation for potential side-effects, with the aim of keeping doctors and patients better informed.

The drugs are under review based on complaints from the public. Inclusion on the list does not mean the U.S. Food and Drug Administration has concluded the drug is dangerous, officials stressed, but that safety reviewers think the reported problem needs to be looked at more closely.

"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research.

"If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently." Source

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

Full post as published by A Georgia Lawyer on September 10, 2008 (boomark / email).