U.S. advisers reject strong epilepsy drug warning
International Herald Tribune - Published: July 11, 2008
By Susan Heavey Reuters
BELTSVILLE, Maryland: Anti-seizure drugs used to treat epilepsy carry an increased risk of suicidal thoughts and behaviour 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 were concerned a strong warning could scare epilepsy patients from being treated with effective drugs.
“I am very concerned … about the risk of unintended consequences of influencing practice and discouraging patients,” said panel member Daniel Pine, of the National Institutes of Health.
The advisers said the suicide risk applied to all epilepsy medications, despite arguments by Pfizer that its two products were better. But there was not enough data to call for the strong boxed caution, the panel decided by a 14-4 vote. Three members abstained.
Epilepsy drugs include Pfizer’s Lyrica and Neurontin, GlaxoSmithKline’s Lamictal , Johnson & Johnson’s Topamax and UCB Inc’s Keppra, among others.
The FDA had proposed adding the boxed warning but sought the advisory panel’s advice before making a final decision.
Some epilepsy drugs already caution about possible suicide.
Similar suicide warnings have been added in recent years to drugs for depression. Some panel members expressed concerns about the effect those cautions 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.
FDA officials said it was too early to see what impact the depression drug warnings had on related suicides but said boxed warnings are meant draw attention to risks, not deter use.
Shares of Pfizer closed unchanged at $18.03 (9 pounds). Glaxo shares fell 0.3 percent to close at $48.40, while shares of Johnson & Johnson gained 1.2 percent to $66.94. Shares of Abbott rose 0.8 percent to $57.35. All four companies trade on the New York Stock Exchange.
(Reporting by Susan Heavey; Editing by Tim Dobbyn)
source: IHT
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