Litigation

FDA Seeks New Warning for Epilepsy Drugs

By Michael Kaplen

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.

Full post as published by Brain Injury News and Information on July 08, 2008 (boomark / email).