FDA Decides Against Warnings
on Epilepsy Medication Suicide Risk |  Email this Page |
By David Gutierrez
NaturalNews
Published January 3, 2009
The FDA has decided against placing new warning labels on anti-seizure medications used to treat epilepsy, in spite of recent findings that those drugs can increase a patient's risk of suicide.
In January, the FDA raised the possibility of labeling 11 anti-seizure drugs with "black box" warnings, after numerous studies linked them to increased risks of suicidal behavior: carbamazepine (marketed as Carbatrol, Equetro, Tegretol and Tegretol XR), felbamate (marketed as Felbatol), gabapentin (marketed as Neurontin), lamotrigine (marketed as Lamictal), levetiracetam (marketed as Keppra), oxcarbazepine (marketed as Trileptal), pregabalin (marketed as Lyrica), tiagabine (marketed as Gabitril), topiramate (marketed as Topamax), valproate (marketed as Depakote, Depakote ER, Depakene and Depacon) and zonisamide (marketed as Zonegran).
The so-called anti-convulsants are used primarily to treat epilepsy, bipolar disorder and migraines.
In early July, the FDA announced its intention to add a black box warning about suicide risk to the drugs' labels. This is the strongest warning that the FDA can place on a product without withdrawing from the market.
The next week, however, an FDA advisory panel recommended against adding a black box warning. While the panel had found, upon review of study data, that there was definitely an association between anti-convulsant use and increased suicide risk, it was concerned that a black box warning might lead to reduced use of the drugs.
"If we have good drugs that are working, we have to be very careful about scaring patients into not taking them," said FDA adviser Rochelle Caplan, of the University of California-Los Angeles.
Following the panel's recommendation, the FDA reversed its position and announced that it would no longer add a black box warning the drugs. The agency's prior advice to doctors still stands, however: to be alert for any changes in the "mood, behavior and actions" of those taking anti-convulsant drugs.
What do you think about the FDA's decision?