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From Pharmalot website:
Congress To FDA: Review Generic Epilepsy Meds
Posted: 17 Nov 2009 04:50 AM PST
Those who take meds to cope with epilepsy will be interested to know that Congress has asked the FDA to examine epileptic drugs the agency considers to be therapeutically equivalent to other products. The disclosure was made in a conference report pertaining to an appropriations bill for the agency.
As the FDA Law Blog posits, the move is presumably related to questions about any “increased risk of seizures or toxic side effects when patients are switched from a brand name to a generic.” The issue has been raised before by the Epilepsy Foundation, the Washington Legal Foundation and a 2008 article in Neurology that changing from a brand to generic may result in seizures.
Pfizer, you may recall, encountered similar concerns last year. That’s when the drugmaker began marketing a new version of its age-old Dilantin med for treating epilepsy. Citing a need to upgrade manufacturing, Pfizer stopped selling Dilantin Kapseals and began selling Dilantin capsules. But some epileptics were complaining that the new product was causing seizures. The agency, meanwhile, is supposedly working on studies to address the problem.