UCB Petition on Anti-epileptic Switching Rejected

FDA has denied a 2006 citizen petition from UCB that sought labeling on all anti-epileptic drugs indicating that “physicians and pharmacists should exercise extreme caution when switching patients who are seizure free or whose seizures are well controlled on a given anti-epileptic drug.” In stating the basis for its request, UCB said that since generic anti-epileptic drugs first became available in the U.S., many patients whose medication was switched have experienced breakthrough seizures or other serious side effects.

In its petition denial letter, the agency said it was not aware of “convincing clinical data that one or more breakthrough seizures leads to an increased likelihood of future seizures in an individual with epilepsy.” It said there is not sufficient evidence to conclude that switching from a branded anti-epileptic to a generic copy increases seizure risks and other side effects.