J.G. Martin had been taking Keppra, a brand of the medication levetiracetam to treat his seizures since April 2007. Two months later, his pharmacist refilled the prescription with a generic version of the drug without his consent. Assuming the generic was just as good as the brand name product that was controlling his seizures, Martin took the medication. But a week later, he began suffering from debilitating migraines.
“I contacted my doctor’s office and was told they suspected the generic,” Martin wrote in a Coping-With-Epilepsy.com message board. “They said they had a lot of patients experiencing the same problem.”
It turns out that not all drugs with the same active ingredient contain the same inactive ingredient. These inactive ingredients include dyes, fillers or other ingredients that some people may be allergic or sensitive to. Keppra is made by UCB, Inc.; however, there are numerous manufacturers who make generics of Keppra, including ANDA made by Mylan Pharmaceuticals.
Aware of the possibility of side effects in patients switching from Keppra to a generic version of the drug, UCB in May 2007 sent a Citizen Petition to the Food and Drug Administration (FDA) urging the agency to order that all antiepileptic drugs contain specific warning information about the possibility of severe adverse reactions in switching patients whose seizures are well controlled on Keppra to a generic brand of levetiracetam.
Mylan Pharmaceuticals countered, sending its own memo to the FDA arguing that UCB “faces an imminent potential loss of exclusivity as the result of pending generic patient challenges brought by Myland and other generic applicants … UCB’s citizen petition is a late-stage attempt to confound and forestall entry of generic Levetiracetam Tablets into the marketplace.”
Martin, however, wishes he were warned. Headaches can be a precursor to his debilitating seizures, and suffering from the migraines caused by generic Keppra was not worth the savings. He switched back to the Keppra brand of levetiracetam and within a week his headaches subsided. “I pay $25 with my insurance for Keppra and paid $15 for generic … it sure is worth the $10 to feel better,” he posted.