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April 21st, 2005

"FDA requests Neurontin study data"

The FDA has requested 14 drugmakers to check their study data to see if use of epilepsy drugs results in suicidal behavior or thoughts, giving the drugmakers six months to respond.

Sales of anti-seizure drugs in the U.S. during 2004 were the fifth- largest drug category, according to research firm IMS Health. Pfizer’s epilepsy drug Neurontin was the best selling anti-seizure medication in 2004, followed by Topamax.

Last year, a law firm asked the FDA to add a black box warning, the agency’s strongest drug warning, about the suicide risks to Neurontin labels. After giving the FDA 261 reports of people who had committed suicide while taking Neurontin, with no attempted suicides prior to the medication, numerous personal injury lawsuits against Pfizer regarding Neurontin were filed. About half of the 261 reported Neurontin users that committed suicide were taking the drug for pain.

Pfizer says more than 10 million people have taken Neurontin, and currently the drug’s prescribing information, a 29-page document that goes to doctors, mentions “suicide gestures” as a rare adverse event. Rare adverse events are considered fewer than one percent of 1,000 patients.

Pfizer’s Warner-Lambert division pleaded guilty to illegally marketing Neurontin to treat ailments it was not FDA approved to treat last year. Prosecutors claim illegal Neurontin promotion boosted sales of the drug, contributing to the 94 percent of prescriptions treating conditions other than FDA approved reasons by 2002.