FDA Seeks Strongest Label Warning for Epilepsy Drugs
The US Food and Drug Administration (FDA) has announced plans to ask that a black-box warning be required of epilepsy drug labels due to an apparent increase in suicidal thoughts and behaviors associated with some of these drugs. A black-box warning on a drug’s label is the strongest warning against adverse side effects allowed of the pharmaceutical industry.
Employing a panel of outside experts assembling for discussion on Thursday, the FDA plans to ask for approval to place the black-box warning label on all drugs approved for treatment of epilepsy, a disease characterized by movements and behaviors that are involuntary and difficult to control.
Government estimates say there are about 2.7 million Americans suffering from epilepsy and 11 drugs have been approved to treat it, including Lamictal, Lyrica, Topamax, and Depakote. Three of the 11 drugs have not produced clear evidence of a tendency toward suicidal thoughts or behaviors but the FDA feels three is enough concern to include all of them in the request for the black-box warning label. This particular issue is one that will be included in Thursday’s panel discussions.
One unspecified drug company says its own studies have reached a different conclusion and representatives from GlaxoSmithKline Plc, maker of Lamictal, are expected at the FDA panel discussion.
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[...] morning’s news includes word the FDA is considering a new warning on epilepsy drugs, stating they can lead to suicide. (To the right, the fine print on such a [...]