WASHINGTON (Reuters) - U.S. Food and Drug Administration officials will seek a strong "black box" warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters on Monday.
"We are going to ask for a boxed warning on these drugs," said FDA spokeswoman Sandy Walsh.
The agency will ask an advisory panel on Thursday to weigh the proposed warning - the strongest possible. The panel 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.
Shares of GlaxoSmithKline were down 1.9 percent to $45.87 and Pfizer shares were off 2.4 percent to $17.33, both on the New York Stock Exchange, exceeding a 1.6 percent decline in the Amex pharmaceutical index .DRG>.
Last month, an FDA analysis concluded epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior. That echoed findings from other data released by the agency earlier this year.
FDA's Walsh said the agency is proposing the black-box warning based on that data, but will seek the panel's input. The agency plans to make its proposal public in documents that could be released later on Monday.
The agency usually follows the advice of its advisory panels.
Representatives for Glaxo and Pfizer had no immediate comment.
