U.S. advisers reject strong epilepsy drug warning

By Susan Heavey

BELTSVILLE, Maryland (Reuters) - 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 (PFE.N) 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 (GSK.L) (GSK.N), Johnson & Johnson's (JNJ.N) Topamax and UCB Inc's (UCB.BR) 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.