Epilepsy drugs may require strictest warning
WASHINGTON - Makers of epilepsy medicines, led by Johnson & Johnson and GlaxoSmithKline PLC, may be required to add the Food and Drug Administration's strictest warning about an increased risk of suicidal thoughts and behavior to their products.
FDA officials said in documents posted yesterday on the agency's website that "it is our intention" to require all 11 approved epilepsy drugs to add the warning in bold-faced type outlined with a black box. The proposal will be considered by outside advisers to the FDA at a meeting Thursday in Beltsville, Md.
Sales of epilepsy drugs, often used to treat psychiatric disorders, topped $10.2 billion in the United States last year. The FDA's analysis of 199 studies found that 0.43 percent of patients on the drugs killed themselves or thought about doing so, compared with 0.24 percent of patients on a placebo. Drug companies and researchers disputed the findings, calling it inaccurate to combine data from medicines that work differently.
"There seems to be no compelling reason to ignore what appears to be a very clear empirical finding of an increase in suicidality, despite no obvious explanation for this finding," said Russell Katz, director of the FDA's Division of Neurology Products, in the documents.
Two panels of outside advisers to the agency are scheduled to discuss how to communicate the risks that were first revealed by the agency in a Jan. 31 notice to healthcare providers. The advisers will weigh whether the warning should be the same for all of the medicines.
The top sellers among the epilepsy drugs were J&J's Topamax and Glaxo's Lamictal, each with 21 percent of the market, according to the research firm IMS Health Inc. About 101.8 million prescriptions were dispensed last year.
Additional products included in the FDA's review are Pfizer Inc.'s Neurontin and Lyrica, Meda AB's Felbatol, UCB SA's Keppra, Novartis AG's Trileptal, Cephalon Inc.'s Gabitril, Abbott Laboratories' Depakote, Eisai Co.'s Zonegran, and carbamazepine, sold by several drug makers.
The FDA found that risks varied for each drug and were statistically significant only for Topamax and Lamictal. Sample sizes may have been too small for the risks to be confirmed for other drugs in the studies, Katz said.
"Since its introduction in the US in 1996, the US prescribing information for Topamax has included suicide attempts in the adverse events section," said Ambre Morley, a spokeswoman for New Brunswick, N.J.-based J&J, in an e-mail yesterday. "We are awaiting the outcome of this week's advisory panel meeting before making any further statements."
