FDA Looks For Suicide Risks Among Epilepsy Drug Users
Lawyer's claims against Neurontin prompt an inquiryApr 21, 2005 | AP
The Food and Drug Administration has begun a preliminary inquiry into whether epilepsy drugs might increase the risk of suicidal behavior in some patients, particularly those who use them for psychiatric illnesses instead of seizure prevention.
Prompted in part by an attorney's claims against the leading anti-convulsant, Neurontin, the FDA last month asked makers of all epilepsy medicines to reanalyze research studies done with the drugs to see if there's any evidence of increased suicide risk.
"I don't think we have any suspicion yet that these drugs actually do that," cautioned Dr. Robert Temple, the FDA's drug policy chief.
It's the same type of analysis that the FDA last year ordered for anti-depressants amid controversy over their use by children and teenagers. Ultimately, those drugs were linked to an increase in suicidal thoughts and actions in a small fraction of young patients.
In addition to use by millions of people with epilepsy, anti-seizure drugs are becoming widely used to treat psychiatric illnesses such as bipolar disorder also called manic depression as well as pain and other conditions. Some epilepsy drugs have FDA approval for various other uses, while others are prescribed "off-label."
A New York attorney last summer filed a petition with the FDA asking that a black-box warning the FDA's toughest about suicide be placed on Neurontin's label. In the petition, Finkelstein cited 25 reports of suicides among Neurontin users from the FDA's own database. The FDA is still investigating the petition.
Pfizer will comply with the FDA's request to reanalyze its studies, but patient data already submitted to the agency "shows no link between Neurontin and suicidal thoughts or behavior," said spokesman Paul Fitzhenry.