FDA Seeks New Warning for Epilepsy Drugs
Roughly 2.7 million Americans have epilepsy, according to government estimates and many forms of epilepsy are caused by a traumatic brain injury.
The Food and Drug Administration is recommending a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of an advisory panel meeting.
The FDA in a memo said that the warning would apply to all epilepsy drugs.
A black box warning is the strongest type of warning that the FDA can compel a drug manufacturer to insert on a product.
Some of the tops selling epilepsy medication that can be affected by the warning are GlaxoSmithKline Plc's Lamictal, Pfizer Inc's Lyrica, Johnson & Johnson's Topamax and Abbott Laboratories Inc's Depakote.
Read the full FDA epilepsy briefing document.
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