American Academy of Neurology Issues New Guidelines for Off-Label Use of Epilepsy Medications
"Frustrated by the drug approval process in the United States," the American Academy of Neurology in San Francisco this week at its annual meeting issued guidelines recommending new epilepsy drugs for "off-label" use as stand-alone treatments, an "unusual step" that "essentially went around" FDA, the Milwaukee Journal Sentinel reports. Only one of the eight epilepsy drugs to enter the U.S. market over the past decade has been approved by FDA as a stand-alone treatment; the rest are approved for use in combination with older drugs. However, researchers in Europe have conducted safety and efficacy tests for the drugs as single treatments. Some of the drugs have European approval for stand-alone use, and AAN researchers say their guidelines are based on a "rigorous and unbiased analysis" of existing research, the Journal Sentinel reports. While the new drugs can cost $1,000 a month, compared with as little as $100 a month for the old treatments, they have fewer side effects and help patients to better control seizures, doctors say. Researchers said the guidelines were necessary to ease some physicians' worries about when and how to prescribe the new drugs. AAN President Sandra Olson, professor of clinical neurology at Northwestern University's Feinberg School of Medicine, said, "The idea is, these are good drugs, and we want them to get used." As some states and insurance companies are trying to cut down on the nearly $2 billion spent annually for the 2.5 million people with epilepsy in the United States, Epilepsy Foundation President Eric Hargis said the guidelines are "good news" for people with the condition, according to the Journal Sentinel (Fauber, Milwaukee Journal Sentinel, 5/2).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.