AES Asks FDA to Ensure Supply of Emergency Medication
West Hartford, November 4 – The American Epilepsy Society (AES) this week asked a U.S. Food and Drug Administration (FDA) advisory committee not to recommend suspension of IV phenytoin, an emergency treatment for potentially life-threatening status epilepticus, until adequate supplies of the replacement drug can be assured. The replacement drug, fosphenytoin, is a more recent formulation having an improved side-effect profile over the older alternative.
In testimony before the FDA advisory committees, AES president Jaideep Kapur called attention to a current nation-wide shortage of fosphenytoin (Cerebyx). “The FDA should ensure that adequate supplies of fosphenytoin are available in the U.S.,” he said, “if it decides to withdraw IV phenytoin.”
The FDA advisory panel met on Wednesday to consider if any action is necessary, or whether to recommend a change in IV phenytoin labeling, or removal of the drug from the market. The panel apparently made decisions that support the AES position.
Fosphenytoin was approved in 1996 for the treatment of epilepsy. Its primary use is in hospitals to treat status epilepticus, non-stop seizures that can result in neurological deficits and, rarely, death if not brought under rapid control.
About the American Epilepsy Society (AES)
The American Epilepsy Society, based in West Hartford, CT, seeks to advance and improve the treatment of epilepsy through the promotion of epilepsy research and education for healthcare professionals. Society membership includes physicians and scientists concerned with the study and treatment of epilepsy (epileptologists) and allied professionals who care for people with seizure disorders
# # #
Information Contacts:
Peter Van Haverbeke Natalie Judd
AES Media Relations Big Voice Communications
703-927-9639 mobile 203-605-9515 mobile
802-375-9011 business 203-389-5223 business