FDA requests review of safety data for epilepsy drugs

The FDA has asked 14 drugmakers to re-examine their data for any evidence epilepsy drugs increase suicidal thoughts or behaviour in patients, USA Today and other new sources report. The FDA requested the review last month, giving drugmakers six months to respond.

The regulatory request is similar to the analysis last year that found a connection between antidepressants and suicidal thoughts and behaviour in young people. The FDA now requires a black box warning on that class of antidepressants. Robert Temple of the FDA's Center for Drug Evaluation and Research says the agency is conducting the review because the links between medications and adverse reactions can be missed "if you don't look properly," USA Today reports. Temple noted it is too early to predict the outcome of the review. "I don't think we have any evidence there really is an increase in suicidality in any of these drugs, but it's the right question to ask."

Pfizer has said it will comply with the review, but denies that Neurontin, which saw sales of $2.6 billion in 2004, increases the risk of suicide. Company spokesman Bryant Haskins commented that "Pfizer maintains an extensive program for tracking and reporting medical events associated with the use of Neurontin," as reported in the San Francisco Chronicle. "The comprehensive data -- including clinical trial results -- that we've submitted to the FDA over the past decade refute any suggestion that Neurontin causes depression, suicidal thoughts or suicidal behaviour," he added.

GlaxoSmithKline spokeswoman Mary Anne Rhyne said that the company is working with the US regulators regarding its epilepsy treatment, Lamictal, and must "reach an agreement with the agency on which clinical trials to include in the analysis" before it can complete its re-examination, The Boston Globe reports. Previously, Glaxo found no increased risk of suicide among bipolar patients taking Lamictal, Ryne added. Johnson & Johnson's Ortho-McNeil, which markets Topamax, also said that they have received and are complying with the FDA's request.

Gregory Barkley, an epilepsy specialist at Henry Ford Hospital in Detroit, indicated he would not be surprised if the review does reveal high rates of suicidal behaviour, USA Today reports. He noted that people with epilepsy have about twice the rate of depression as the general population. "I doubt that one anti-convulsant will be any worse than others," Barkley noted.

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