Low-dose fenfluramine (Fintepla), Approved to Treat Seizures Associated with Dravet Syndrome in Those Age 2 and Older

The FDA announced that low-dose fenfluramine (Fintepla), a Schedule IV controlled substance, was approved to treat seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a rare, life-threatening form of epilepsy often characterized by intractable seizures.

Fenfluramine will carry a boxed warning about its association with valvular heart disease and pulmonary arterial hypertension. Patients using the drug must have an echocardiogram before, during, and after treatment.

Because of these risks, fenfluramine will be available only through a restricted drug distribution program under a risk evaluation and mitigation strategy (REMS). The REMS will require prescribers and pharmacies to be certified in the program. Patients must be enrolled and must adhere to required echocardiogram monitoring.

Learn more on the FDA website.