Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

Exclusion Criteria

• •1. Patients with mild or greater mitral valve regurgitation and/or trace or greater aortic valve regurgitation will not be eligible for participation. The clinical statement can be submitted first for initial, conditional approval and then ECHO results can be submitted at a later date for final approval.
• •2. Patients with failure to thrive will not be eligible for participation as fenfluramine can suppress appetite and has a risk for weight loss. Failure to thrive will be evaluated on the following criteria:
• •1. Weight less than the 2nd percentile.
• •2. Lack of weight gain that crosses two or more of the major percentile lines and is not congruent with length.
• •Inclusion of patients will be at the sole discretion of the multi-PIs based on a majority vote.