Did the FDA speak too soon when it slapped a suicide warning on a class of epilepsy drugs? New research suggests so. A study of 5 million patients, published in the New England Journal of Medicine, now has found that the suicide risk is linked not to the drugs, but to the disorders the drugs are prescribed to address. Added to recent research that linked some of the epilepsy drugs in question with suicide risk--but not others--the data has at least one expert saying the FDA should pull the warning.
The FDA added the warning after reviewing data from 199 studies that suggested that patients using these drugs did have a higher risk of suicidal behavior than other patients did. But the FDA study didn't cover nearly as many patients, and while the agency research had 24 weeks follow-up, the new study followed patients for six years, HealthDay reports.
"The warning on AEDs and suicide was never justified, and this data strongly argues for its removal," says Dr. Orrin Devinsky, director of the New York University Comprehensive Epilepsy Center, as quoted by HealthDay.
There are two subgroups of patients that did show an increased suicide risk in the new study: Those with depression and those who weren't using the epilepsy drugs for epilepsy, depression or bipolar disorder. The reason for the former risk could be attributed to depression itself, the study authors said; it may be that only patients with severe depression are given these meds rather than antidepressants. The latter? The researchers aren't sure.
Among the drugs studied were Pfizer's Neurontin (gabapentin), GlaxoSmithKline's Lamictal (lamotrigine), UCB's Keppra (levetiracetam), and Novartis' Trileptal (oxcarbazepine). The FDA has not responded yet.
- here's the study abstract
- read the HealthDay story
- get more from Reuters
- see the Bloomberg article