US FDA may call for black box warnings on epilepsy drugs; advisory meeting due
The US Food and Drug Adminsitration is likely to call for black box warnings to be placed on epilepsy drugs to highlight their risk of suicidal thoughts and behavior.
The statement came before a panel of outside experts meets on July 10 to discuss the issue after an FDA meta-analysis of 199 controlled trials, conducted earlier this year (Marketletter February 11), yielded an overall odds ratio for suicidality of 1.80, indicating a statistically-significant increase in episodes compared to placebo, and implicating a total of 11 different drugs.
Black box warnings are the strictest type of safety restriction the agency can place on a drug. The biggest earners in this category are UK drug major GlaxoSmithKline's Lamictal (lamotrigine) and world drug giant Pfizer's Lyrica (pregabalin). According to IMS Health figures, these two products command a 21% share of the epilepsy market.
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