Panel rejects strong epilepsy drug warning

By Susan Heavey

BELTSVILLE, Maryland (Reuters) - Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday.

Members of the Food and Drug Administration's panel of outside experts rejected the agency's proposed caution, expressing concern that a strong warning could scare epilepsy patients from being treated with effective drugs.

"We need to be very careful about scaring the patients into not taking their drugs," said panelist Rochelle Caplan, a professor of psychiatry at the University of California in Los Angeles.

The FDA, which sought the panel's advice, will make the final decision. The agency usually follows the advice of its advisory panels, but could still implement the boxed warning.

Agency officials said their analysis of available data pointed to greater suicidal complications in patients taking nearly a dozen epilepsy medications, including Pfizer Inc's Lyrica and Neurontin, GlaxoSmithKline Plc's Lamictal, Johnson & Johnson's Topamax and UCB Inc's Keppra, among others.

The medications brought in more than $10 billion in 2007 sales, according to healthcare information company IMS Health.

Some epilepsy drugs already carry cautions about possible suicide, and officials from Glaxo said they agreed with the FDA's findings. But Pfizer argued its products showed no such risk and should be exempt from a black box warning.

The advisers said all epilepsy medications should include some warning about possible suicide, but not a black box.

"It feels like taking a canon to an issue where we don't really have a clear, definitive idea about ... the most appropriate action to take," said panelist Daniel Pine, head of child research at the National Institute of Mental Health.

Similar boxed warnings have been added in recent years to drugs for depression. Some panel members expressed concerns about the effect they had on patients, noting that anti-depressant prescriptions have declined.

"What we saw ... was a real scare factor," said Gail Griffith, a consumer representative on the panel.

But unlike antidepressants, data shows epilepsy drugs are clearly effective, the panelists said.

FDA officials said it was too early to see what impact the depression drug warnings had on suicides but said boxed warnings are meant draw attention to risks, not deter use.

"It doesn't mean don't use this drug. It means pay attention," said Robert Temple, who oversees one of the FDA's drug evaluation offices.

After the meeting, FDA officials said they would discuss the panel's advice and expected to make a decision soon.