Summary of Case Reports (I)

Single reports received through August 29, 1997

Fenfluramine + phentermine 85

Fenfluramine alone 3
Dexfenfluramine alone 9
Fen-phen and dexfen (not concomitantly) 4

(includes 24 cases from Mayo article)

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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.