Interim Results of the US Fenfluramine Oral Solution Cardiovascular Safety Registry Study (S12.002)

Here we provide interim results from the FDA-required post-marketing cardiovascular (CV) safety registry study. The objective is to characterize the risk of valvular heart disease (VHD) and/or pulmonary arterial hypertension (PAH) as defined by the Risk Evaluation and Mitigation Strategy (REMS) in patients exposed to fenfluramine (FFA, FINTEPLA®) in the US.