Epilepsy drugs to add warning
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from times wire services
Epilepsy drugs must carry a new warning about the risk of suicidal thoughts or actions, as urged by a Food and Drug Administration advisory panel in July. The FDA announced changes to the drugs’ prescribing information in a statement on its website.
In keeping with the recommendations of its advisors, the FDA rejected a proposal to require that the drugs carry the agency’s strictest caution, outlined in a black box.
This year, regulators reviewed 199 studies of 11 epilepsy drugs and found 80% more suicidal thoughts and behavior in patients taking the drugs.