Slide 3 of 16

1. Through August 29, 1997, FDA has received 85 reports of valvular disorders in patients treated with fenfluramine in combination with phentermine primarily through the MedWatch program. An additional 3 reports with fenfluramine alone and 9 reports with dexfenfluramine alone have also been received. In 4 other reports, patients were treated with fenfluramine-phentermine as well as dexfenfluramine, and it was not possible to determine which exposure was associated with the valvulopathy.