New Study Suggests Different Versions of the Same Epilepsy Medication Can Be Harmful

New Study Suggests Different Versions of the Same Epilepsy Medication Can Be Harmful

Washington, D.C., May 7, 2009— The Epilepsy Foundation announced findings today that show people with epilepsy, whose seizures have been controlled with a consistent drug therapy, have a greater chance of increased seizures, greater side effects or sudden death when their medications are switched from one version of an antiepileptic drug (AED) to another, whether the switch is brand-to-generic, generic-to-brand or generic-to-generic.

“We strongly urge the Food and Drug Administration to inform patients and their doctors about the possible dangers of medication switching, and we’re calling on the FDA to do more research into this matter and to develop a standard that ensures equivalency and safety for all patients,” said Eric R. Hargis, president and CEO of the Epilepsy Foundation.

The study, which surveyed more than 1,000 people with epilepsy, reveals that seizures worsened for 59 percent of people who had switched from a brand-name to a generic AED, while side effects increased for 49 percent of that same group. Additionally, seizures worsened for 15 percent of those who had switched from a generic to brand AED, while side effects increased for 18 percent of that same group. Furthermore, more than 25 percent of respondents reported experiencing problems after switching between different generic formulations of an AED.  

“Brand names of medications have different formulations than their generics, and generics also vary from each other—in the exact amount of active ingredients in the drug as well as with the amount and type of filler ingredients included. While these variations might not mean much with some medications, for others, like AEDs, they can mean the difference between being seizure free and suddenly having a seizure while driving on the freeway,” said Dr. Brien Smith, senior staff neurologist and medical director of the Comprehensive Epilepsy Program at Henry Ford Hospital.

The Epilepsy Foundation is filing a Citizen’s Petition seeking action from the agency, and has taken the initiative to inform members of the health care and epilepsy communities about concerns raised in the recent studies. In addition, alerts were sent to neurologists and pharmacists across the country, and a site was created that includes comprehensive information on medication switching and a forum for people with epilepsy and their caregivers to share anecdotal evidence about their experiences with medication switching.

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