Neurology Academy Does End Run Around FDA

Ken Rankin
Published Online: Thursday, July 1, 2004

In an end run around the FDA approval process, one of the nation's top medical societies is advising physicians to prescribe several new epilepsy drugs for "off-label" indications.

New guidelines issued by the American Academy of Neurology during the group's annual meeting in San Francisco, Calif, affect a number of new drugs introduced during the past 10 years. Although these products have been approved by the FDA for use along with older epilepsy drugs, they have not been approved as stand-alone treatments.

Members of the academy contend that the current requirements are unnecessary and even dangerous for many epileptics because the older seizure-control drugs pose a higher risk of adverse side effects. The FDA, however, has refused to approve the new treatments as single-use drugs until they are proven effective in clinical trials involving a placebo control group. Such studies are unlikely to be conducted, however, because few epileptics are willing to go without their old medication and risk seizures if they are given placebos.

The architects of the new prescribing guidelines contend that there is little risk for epileptics taking the new drugs off-label because these medications have been found to be safe as stand-alone treatments by researchers in Europe.

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