FDA's "Hit List" List of Drugs With Potential Safety Concerns Features the Usual Suspects

The FDA published a list of drugs that have developed safety signals worth reviewing in its adverse event reporting system. The list doesn’t mean the drugs are dangerous, just that routine monitoring has thrown up a list of candidates that should be studied to see if there’s more danger there than meets the eye.

Here’s some of the highlights, courtsey of Reuters, followed by some commentary:

• Abilify - Bristol-Myers Squibb Co
  This drug is already the subject of criticism from the patient underground.

• Xenical - Roche
  If this drug has problems (rectal bleeding, in this case) then GlaxoSmithKline could have more problems on its OTC version, Alli.

• Prozac - Eli Lilly
• Zoloft - Pfizer
• Lexapro - Forest
• Celexa - Forest
  These antidepressants are already the subject of a debate over whether they actually work or not.

• Lamisil - Novartis
  Lamisil already carries this warning: “Cases of liver failure, some leading to death or liver transplant, have occurred with the use of oral terbinafine during postmarketing experience in individuals with and without pre-existing liver disease.” Other side effects include decreases in white blood cell count and changes in the retina and lens of the eye. Given that this is a drug for toenail fungus, one presumes the risk-benefit equation weighs heavily in favor of the latter.

• Diovan - Novartis

• Plan B - Teva
  Always controversial, for both its advertising and the fact that some doctors refuse to prescribe it.

Here’s FDA’s definition of the list:

… any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

Hat tip to Internet Drug News, which saw this first.