On June 25,2020, the FDA approved FINTEPLA® (fenfluramine) oral solution for the treatment of seizures in Dravet syndrome for patients 2 years and older. As part of the approval, the FDA required a black box warning on the medication. Additionally, the FDA requires the enrollment of patients taking FINTEPLA into a Risk Evaluation and Mitigation (REMS) program.
Clinical trials did not identify any clinically significant issues related to heart health associated with FINTEPLA. While some patients did have trace or mild findings that resulted in an abnormal echocardiogram report, without other structural abnormalities accompanying these changes, the findings are considered physiologic or normal. However, the active ingredient in FINTEPLA, fenfluramine, is part of a class of drugs that affect a specific serotonin receptor (5-HT2B), and these types of drugs have previously been associated with more serious heart conditions. Due to those previous associations, it is important to closely monitor patients on FINTEPLA. Out of an abundance of caution, the FDA recommended the black box warning and the inclusion of the REMS program to monitor patient heart health before, during, and after taking FINTEPLA.
The REMS program will require patients to receive echocardiograms before starting FINTEPLA, every six months while on FINTEPLA, and within 3 to 6 months after stopping FINTEPLA. If patients have an abnormal echocardiogram while on FINTEPLA, physicians will need to discuss the risks and benefits of remaining on FINTEPLA with the patient or caregiver. Both patients and their prescribing physicians will be need to register for the REMS program and complete a brief educational training. These trainings require minimal time investment. Pharmacies are also required to register for the REMS program before dispensing FINTEPLA. More information on FINTEPLA and the REMS program can be found here.