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WASHINGTON, USA - EPILEPSY drugs are associated with a higher risk of suicidal thoughts or behaviour, US regulatory reviewers said in an analysis released on Wednesday.
'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.
Epilepsy drugs include Pfizer Inc's Lyrica, GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax, and Abbott Laboratories Inc's Depakote.
The findings were similar to conclusions the FDA announced in January. Agency officials have said they are working with drugmakers to add information about the risk to the prescribing instructions for the drugs.
Ms Kara Russell, spokesman 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 labelling since the beginning.' UCB SA spokesman Andrea Levin said prescribing instructions for its epilepsy drug, Keppra, already include data on suicidal behaviour reported in clinical trials, and the company would comply if the FDA asked for changes.
Representatives of other makers of the drugs could not immediately be reached or had no immediate comment.
The FDA staff review was released ahead of a July 10 meeting of a panel of outside advisers that will be asked for input on the issue.
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