Recently, the company that manufactures the prescription medication Mebaral CIV (brand of mephobarbital tablets), Lundbeck, notified the Food and Drug Administration (FDA) that this medication would no longer be produced. The company anticipates its limited existing supply will be depleted by the end of 2011. This information was communicated to physicians and wholesalers on January 17, 2011 in order to provide as much time as possible for physicians and patients to identify and transition to alternative therapies.
For anyone who was using this therapy, the Epilepsy Foundation strongly encourages you to immediately discuss alternative treatments and therapy transitioning with your neurologist or health care provider.
Mebaral was developed in a previous era to treat seizures and few people with epilepsy remain on the drug today. The drug was marketed before FDA approval was necessary. Therefore, Mebaral has never been FDA approved. There is no generic equivalent to Mebaral. At this time, the Foundation understands that the drug will not be submitted to the FDA for approval, and will cease to be manufactured.
It seems likely that this decision has resulted from increasing enforcement of unapproved drugs by the FDA which began with a 2006 drug safety initiative to remove unapproved drugs from the market. For more information from the FDA on unapproved drugs: Read on the FDA Site
Article from the May 2011 Epilepsy.com Spotlight Newsletter. Other articles in this issue inclue: