UPDATE – 11/07/08: The FDA’s advisory panel recommended not adding the ‘black box’ warning to epilepsy drugs, HealthDay News reports.
The US Food & Drug Administation (FDA) will consider Thursday whether to slap the ominous “black box” warning, its strongest caution, on 11 drugs used to treat epilepsy. The medications appear to increase suicide risk.
The FDA’s recommendation comes after it completed a meta-analysis of nearly 200 experiments with medications such as Depakote, Tegretol, and Lyrica (see the full list of drugs at Medical News Today). The study, released earlier this year, found that risk of suicidal thoughts and actions nearly doubled in patients taking epilepsy drugs, compared with a placebo group — although the risk remained below 0.5% even for the patients receiving drugs.
The agency will meet with its advisory committee to discuss the findings, and whether a warning label should be affixed to all or some of the drugs. While the FDA is not required to follow advisors’ recommendations, it usually does.
The 11 medications in question are used to treat migraines, chronic pain and psychiatric disorders, as well as the seizures that afflict an estimated 2.7 million Americans. The market for anti-seizure meds is more than $8 million per year, and Pfizer stands to lose the most over its drug Lyrica, says the Wall Street Journal.
The studies in the meta-analysis encompassed more than 43,000 patients, with approximately 2/3 receiving medication and the rest on dummy pills. Four patients committed suicide while on medication; none in the placebo group did so. See a summary of the results at Medscape (free subscription required).
The FDA has no explanation for the suicide link, and drug companies are likely to argue that it’s unfair to compare different medications across different studies. Three of the 11 drugs didn’t show clear evidence of suicide risk. However, the FDA is interested in black box warnings for all of the medications, because of concern that the sample size was too small to register a risk in some experiments.
Posted on behalf of Amber Dance