FDA Panel Votes For No Black Box Warnings On Epilepsy Drugs
July 10, 2008
Boston (dbTechno) - A U.S. Food and Drug Administration (FDA) panel has voted against black box warnings on epilepsy drugs.
A black box warning is the toughest warning that the FDA can give, but a panel has recommended on Thursday not to issue this warning to several epilepsy drugs.
The FDA panel voted 14 to 4, with 3 abstentions against the black box warnings.
The reason for the vote was due to the fact that the studies did not showcase a high enough risk for suicidal behavior tied to the drugs.
The panel did vote in favor of informing doctors about the risks of suicide with the drugs. Doctors will be sent a medication guide to help inform them of the risks.
This comes just days after the FDA stated they wanted black box warnings on more than 10 epilepsy drugs.
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