FDA Reviewing Abilify For Liver Toxicity, Anti-Depressants For Birth Defects

The FDA announced yesterday that it is reviewing the safety of a bunch of drugs, including Abilify and several anti-depressants. As usual, I cannot find notice of this on the FDA's website (it's supposed to be here, but it's not yet), so going from Reuters' account of things, here's what's up:

Abilify is being reviewed by the FDA due to reports of liver toxicity and "other issues." I have no idea what the other issues are at the moment. You can go to the lovely fdable.com website and look at specific liver issues related to Abilify use. You can go here and see about 200 pages of adverse events reports filed with the FDA over Abilify.

As for anti-depressants:

"In addition, the agency said evaluating the risk of birth defects with widely-used SSRI and SNRI antidepressants, which already carry strong warnings about suicidal behavior.

"Well-known antidepressants include Eli Lilly and Co's Prozac, Pfizer Inc's Zoloft, GlaxoSmithKline Plc's Paxil and Forest Laboratories Inc's Lexapro and Celexa."

It's not clear from this which anti-depressants the FDA is looking at, but it's a safe bet one of them is Paxil. The company already faces lawsuits over birth defects allegedly related to Paxil use during pregnancy.

As usual, the fact that the FDA is reviewing the safety of these drugs doesn't mean that the FDA has concluded the drugs have that problem. That will come later. Ought to be interesting to see where the agency goes with all this.