FDA Looking at 20 Drugs for New Adverse Events

The FDA is “evaluating” 20 drugs that have been associated with various adverse events – all of the drugs are currently on the market. The events occurred between Jan. 1 and March 31, 2008, but the FDA says it will be "weeks or months" before they have any new reports on the medications.

Though the drugs are suspect, the FDA cautions that just because it might be on the list, it doesn’t mean you should stop taking it, or that the medication will even cause problems. One of the medications being watched is Nitroglycerin, used for heart patients for the treatment of angina. The “Potential Signal of Serious Risk/New Safety Information” associated with Nitroglycerin is “overdose due to labeling confusion”. Humulin U 500 (Humulin R) Insulin carries the potential of “dosing confusion”.

Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology says, "If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation." In 2007, a federal law was passed requiring the FDA to disclose investigations the agency makes into the possibility of any adverse events related to drugs. The current list is the first quarterly report.

The FDA collects data from hospitals, physicians and patients regarding adverse drug events as part of their Adverse Event Reporting System (AERS).

Drugs on the FDA Watch List

The drugs on the list, including the concerns, are listed below:

Arginine Hydrochloride Injection (R-Gene 10):
Pediatric overdose due to labeling / packaging confusion

Desflurane (Suprane):
Cardiac arrest (heart stops working)

Duloxetine (Cymbalta):
Urinary retention

Etravirine (Intelence):
Hemarthrosis (blood in a joint)

Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric):
Adverse events due to name confusion

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

If you take any of these medications, and have any problems, please report it to MedWatch, the FDA’s online voluntary reporting system. For information about medication, you can call 1-888-INFO-FDA.

Source: http://www.medscape.com/viewarticle/580145

Patient Deaths Spark Stronger Warnings for TNF Blockers