New Suicide Warning for Epilepsy DrugsJun 12, 2008 | Parker Waichman LLP
United States drug reviewers just announced that epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior. The analysis was released this week and confirmed earlier findings. "The effect appears consistent among the group of 11 drugs" that were reviewed, according to a summary from statistical reviewers at the Food and Drug Administration (FDA). In the review dated May 23, the FDA staff said that there were about two more cases of suicidal thoughts and behavior per every 1,000 patients given the drugs versus those given a placebo. In January, the FDA released similar findings, according to FDA spokeswoman Sandy Walsh.
The epilepsy drugs include Pfizer Inc.'s Lyrica, GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax, and Abbott Laboratories Inc.'s Depakote. FDA officials said that they are working with the drug makers to add information about the suicidal behavior risk to the prescribing instructions for these drugs. Also, a panel of outside advisers to the FDA is scheduled to discuss the issue next month, on July 10.
The FDA staff reviewed 199 trials involving about 44,000 patients who were given either an epilepsy drug or a placebo. Some of the epilepsy medicines are also approved for depression, migraines, and other conditions. As a result, four patients given drug treatment committed suicide, compared with zero suicides in the group who received the placebo, according to the FDA staff review. Generally, approximately 0.4 percent of drug-treated patients reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients.
In January, the FDA warned that all patients taking epilepsy drugs should be closely monitored for changes in behavior that could indicate either suicidal thoughts or behaviors or depression. Kara Russell, spokeswoman at Johnson & Johnson's Ortho-McNeil Neurologics Inc. unit—the group that makes Topamax—said the company was reviewing the FDA's report and confirmed that language about possible suicide behaviors or attempts "has existed in our labeling since the beginning." UCB SA spokeswoman, Andrea Levin, said prescribing instructions for its epilepsy drug, Keppra, already included data on suicidal behavior reported in clinical trials. Levin advised that UCB SA would comply if the FDA asked for changes.
A Glaxo analysis of Lamictal found a trend for suicidal thoughts and behavior that was similar to that found in the FDA analysis, according to company spokeswoman, Holly Russell. Glaxo is currently working with regulators to update the drug label, she said. Abbott spokeswoman Laureen Cassidy said the company would work with the FDA to implement any changes requested for the class of drugs.
Epilepsy is a neurological condition that, from time-to-time produces brief disturbances in normal electrical brain functions. When someone has epilepsy, normal electrical brain patterning may be interrupted by intermittent bursts of electrical energy that are much more intense than usual. These interruptions and bursts may affect a person's consciousness, bodily movements, or sensations for a short time and are called epileptic seizures and are why epilepsy is sometimes called a seizure disorder. The bursts may occur as partial seizures affecting just one area of the brain or can be generalized, affecting nerve cells throughout the brain.