Drug approved to treat infantile spasms

Abstract

FDA and Lundbeck Inc. on August 21 announced the approval of vigabatrin, or Sabril, for the treatment of infantile spasms and as add-on therapy for the treatment of complex partial seizures in adults. The agency said the oral antiepileptic drug is the first U.S.-approved medication for the treatment of infantile spasms, which are difficult to control. Permanent vision damage, ranging from mild to severe, has occurred in both eyes of at least 30% of patients exposed to vigabatrin, the company said. Patients of all ages and at any time during therapy have been affected. The product’s FDA-approved labeling has a boxed warning alerting health care professionals to the possibility that vigabatrin users may lose peripheral vision in both eyes and have difficulty visually differentiating between objects. Because of the risk of permanent vision damage, FDA said, vigabatrin is available only through a restricted distribution program, which Lundbeck has named Support Help and Resources for Epilepsy, or SHARE.