FDA Warns About Certain Epilepsy Drugs

The FDA has published a warning concerning certain drugs designed to treat epilepsy and certain psychiatric disorders. The warning coming amidst increasing agency concern that the drugs have shown an increased risk in suicide and suicidal ideation. The drugs include Topamax by Johnson & Johnson, Lamictal by GlaxoSmithKline PLC, Pfizer Inc.’s Lyrica and Neurontin, and Novartis AG’s Tegretol and Trileptal.
While the new warnings will caution consumers and doctors about the harmful side effects, they fall short of the “black box” warning reserved for the FDA’s harshest warning label. The new warning has drawn criticism from the American Epilepsy Association which stated that the FDA’s conclusions were flawed and the warnings raise concern that the new warning will cause patients to cease treatment, exacerbating the epileptic and psychiatric issues.
The pushback from the American Epilepsy Association is symptomatic of the reaction to the FDA’s new emphasis on drug safety. The federal agency must walk a fine line between advocating consumer safety and the risk to benefit analysis drug manufacturers purport in treating patients. It’s an understandable debate. Normally, one could take solace that good science could serve as the final arbiter. Yet, the federal government is probing how scientists and doctors can be influenced by payments from pharmaceutical companies in return for their promotion of a certain drug. This confluence of factors and competing interests makes drug safety and patient care murky at best.