Neurology Academy Does End Run Around FDA

Pharmacy Times, Volume 0, 0

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

New guidelines issued by the American Academy of Neurology duringthe group's annual meeting in San Francisco, Calif, affect a number ofnew drugs introduced during the past 10 years. Although these productshave 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 unnecessaryand even dangerous for many epileptics because the older seizure-controldrugs pose a higher risk of adverse side effects. The FDA, however, hasrefused to approve the new treatments as single-use drugs until they are proveneffective in clinical trials involving a placebo control group. Such studies areunlikely to be conducted, however, because few epileptics are willing to gowithout their old medication and risk seizures if they are given placebos.

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