Potiga ezogabine regulatory update

FDA approved an updated label for Potiga ezogabine from Valeant and GlaxoSmithKline with a boxed warning about retinal abnormalities and potential vision loss with the use of the seizure drug. FDA advises that Potiga be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures or epilepsy and for whom the benefits of treatment outweigh the risks. The agency recommends patients have eye exams by an ophthalmic professional before initiating Potiga and every 6 months during treatment. The updated label includes warnings regarding the risk of discoloration of the skin, nail, mucous membrane and white-of-the-eye. FDA issued a drug safety communication warning on Potiga in April (see BioCentury, May 13). ...