We continue to receive reports from folks who have suffered breakthrough seizures after being switched from the name brand antiepileptic drug Keppra to generic levetiracetum. Because most health plans encourage the use of generic drugs over higher cost name brand drugs, and most states allow pharmacies to substitute generic drugs for name brand drugs if the generic is considered equivalent, many patients whose seizures are well-controlled on Keppra are being switched to generic levetiracetum unaware of the considerable risks of breakthrough seizures. For those individuals who have been seizure free on Keppra, the results can be devastating – lost jobs and revoked drivers’ licenses. Individuals in remission for long periods are especially at risk as they are more likely to be engaged in potentially dangerous activities such as driving a car or operating machinery. Deaths resulting from breakthrough seizures have already been reported.
In contrast to FDA regulations for new drug applications (NDAs), which require submission of clinical trials and a description and analysis of any other data or information relevant to an evaluation of the safety and effectiveness of the drug, the regulations for abbreviated new drug applications (ANDAs), the process required for generic equivalents, only require that the submission include information that shows that the generic is bioequivalent to the name brand drug. However, generic drugs are pharmaceutical equivalents only with respect to their active ingredients, and current regulations allow for up to a 20% variation in the bioavailability of the drug once ingested. The binders, diluents, and fillers in the formulation of the drug, as well as the method of manufacture, vary from name brand to generic to generic.
Numerous medical studies have reported the dire consequences of switching epilepsy patients from name brand drugs to generics. The American Epilepsy Society issued a Position Statement in 2007 opposing the substitution of antiepileptic drugs without patient and physician approval. Unfortunately, the generic manufacturers of levetiracetum are not warning patients that their products are not identical to the name brand Keppra, and the dire consequences seen in the past with switching epileptic patients from name brand to generic are now being seen with Keppra, the most recent drug to have gone off patent. Our firm is evaluating cases involving injuries resulting from being switched from Keppra to generic levetiracetum. Please contact Roger Smith, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com if you have any questions.