The Epilepsy Foundation announced a new report of survey data obtained from more than 1000 consumers who report an increased risk of seizures and side effects when they have switched from one manufacturer’s formulation of an antiepileptic drug (AED) to another. The switch can be between different manufacturers’ versions of the same generic drug, from a generic to the brand-name drug, or from the brand-name drug to a generic. It can also be caused by a switch from one manufacturer’s formulation of its antiepileptic drug to a new formulation of the same drug. The Foundation’s just-released survey tells the stories that too many individuals have experienced, and supports other newly published studies documenting that switching can cause breakthrough seizures and severe, unexpected side effects.
While most patients can safely switch their medications among different formulations of the same antiepileptic medication, the Epilepsy Foundation recommends that consent must be obtained from the individual with epilepsy and their physician before any such substitutions are made – to avoid potentially life-threatening seizures. Too many people have been harmed; some have even died as a result of an unsupervised switch.
The Epilepsy Foundation is calling on the Food and Drug Administration (FDA) to develop new standards for determining the equivalence of antiepileptic products, and until that happens, asks the agency to alert patients, prescribers and pharmacists about this patient safety issue. The Foundation and its experts also call upon the agency to conduct postmarketing surveillance on all antiepileptic drug switches, and to make the research results available to the public and prescribing physicians. The FDA’s mandate to ensure safety and efficacy of antiepileptic drugs, and its knowledge of the problem, based upon years of data presentations and petitions asking the agency to address the concerns about equivalence standards for such drugs, require it now to finally take action to ensure that people can reliably count on their medications not to cause them harm.
Multiple studies show an increased risk of a breakthrough seizure when patients switch. The FDA claims the antiepileptic medications work exactly the same in every patient; however, the majority of neurologists in the U.S., the Epilepsy Foundation, the American Epilepsy Society, the American Academy of Neurology and the International League Against Epilepsy all disagree with the FDA and cite evidence documenting that patients should not switch without their doctor’s consent.