The product labeling for Pondimin (fenfluramine HCl) has been revised to convey the final evaluation of the International Primary Pulmonary Hypertension Study. PONDIMIN IS AN APPETITE SUPPRESSANT, AND APPETITE SUPPRESSANTS INCREASE THE RISK OF DEVELOPING PRIMARY PULMONARY HYPERTENSION (PPH), AN OFTEN FATAL DISORDER. Use of appetite suppressants for longer than 3 months is associated with a 23-fold increase in the risk of developing PPH. Therefore, the risk associated with the long-term use of appetite suppressants is estimated to be about 23 to 46 cases per 1 million persons per year. Pondimin is contraindicated in patients with glaucoma, in patients with hypersensitivity to fenfluramine or related agents, and in patients taking (or within 14 days of discontinuing) an MAO inhibitor. This drug should not be used by patients with a history of drug abuse, nor in those patients with alcoholism or psychotic illness. Potent anesthetic agents should be administered with caution in patients taking Pondimin and other CNS-depressant drugs should be used with caution. Pondimin is not recommended for pregnant or lactating women or for pediatric patients. The maximum recommended dose (120mg/day) should not be exceeded. Concomitant use of Pondimin with other weight-loss agents is not recommended. The use of phentermine and fenfluramine ("fen/phen") concomitantly is not an approved use of Pondimin
