WASHINGTON Epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior, U.S. drug reviewers said in an analysis that was released on Wednesday and mirrored 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. There were about two more cases per every 1,000 patients given the drugs instead of a placebo, the FDA staff said in a review dated May 23.
The findings are similar to data released by the FDA in January, agency spokeswoman Sandy Walsh said.
Epilepsy drugs include Pfizer Inc's Lyrica, GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax, and Abbott Laboratories Inc's Depakote.
Agency officials have said they are working with drugmakers to add information about the suicidal behavior risk to the prescribing instructions for the drugs.
A panel of outside advisers to the FDA is scheduled to discuss the issue on July 10.
The FDA staff reviewed 199 trials involving about 44,000 patients who were given an epilepsy drug or a placebo. Some of the medicines also are approved for depression, migraines and other conditions.
Four patients given drug treatment committed suicide, compared with zero who got a placebo, the FDA staff review said. Overall, about 0.4 percent of drug-treated patients reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients.
In January, the FDA said all patients taking epilepsy drugs should be closely watched for behavior changes that could indicate suicidal thoughts or behavior or depression.
Kara Russell, spokeswoman at Johnson & Johnson's Ortho-McNeil Neurologics Inc unit that makes Topamax, said the company was reviewing the agency's report but added that language about possible suicide "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, and the company 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 the FDA analysis, company spokeswoman Holly Russell said. Glaxo is 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.
Representatives of other makers of the drugs could not immediately be reached or had no immediate comment.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Phil Berlowitz and Carol Bishopric)