U.S. Food and Drug Administration officials are pushing for a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of a public meeting on the issue.
"We are going to ask for a boxed warning on these drugs," US FDA spokeswoman Sandy Walsh said. The warning would apply to all epilepsy drugs, even those that showed no risk signal. The US FDA will ask an advisory panel on 10th July, to weigh the proposed boxed warning — the strongest type the agency can seek. The panel of outside experts is set to discuss risks with drugs to treat the disease, which is marked by seizures that can cause involuntary movement or behavior.
GlaxoSmithKline Plc's Lamictal and Pfizer Inc's Lyrica are among the top-selling epilepsy drugs. Others include Johnson & Johnson's Topamax and Abbott Laboratories Inc's Depakote. Some epilepsy drugs, which are given to prevent seizures, bring in billions of dollars a year. In 2007, Lamictal sales were $2.2 billion and Lyrica sales were $1.8 billion.
Roughly 2.7 million Americans have epilepsy, according to government estimates. Last month, an US FDA analysis concluded the medicines are associated with a higher risk of suicidal thoughts and behavior. That echoed findings from other data released by the agency earlier this year. According to the US FDA, three of the 11 drugs studied showed no clear signal of suicidal problems.
Pfizer maintains its drug is safe and effective as currently labeled. Glaxo spokeswoman Sarah Alspach said the results of the US FDA's analysis should be included on drug labels for epilepsy drugs and that further research was needed.