FDA requests anticonvulsants be reexamined
By Liz Kowalczyk
The Boston Globe
April 20, 2005
The Food and Drug Administration has asked the makers of epilepsy drugs, which are the fifth best-selling group of medications and are taken by millions of Americans, to reexamine their data to determine if the drugs increase patients' risk of suicide.
The agency has requested an analysis similar to the one it commissioned to evaluate whether antidepressants pose a similar risk to children and teenagers. That sweeping reexamination of clinical trial data found that antidepressants can increase suicidal thoughts and behavior in young people, and last year the FDA required manufacturers to include a stronger, more prominent warning, known as a ''black box," on the drugs' labels.
The agency, which has been the target of growing criticism from members of Congress over how it monitors drug safety, is under pressure to more carefully scrutinize anticonvulsants, particularly Neurontin, which is made by Pfizer Inc. and is the market leader.
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