January 1997

Dear Health Care Professional:

Enclosed for your review is the revised PONDIMIN (fenfluramine HCl tablets) C-IV product labeling. As you know, PONDIMIN is indicated for the management of exogenous obesity as a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction. PONDIMIN should be prescribed only for appropriate patients and not for cosmetic weight reduction. As part of a responsible weight-loss program, PONDIMIN should be used in combination with regular exercise, dietary restriction, and behavioral modification. In those patients deemed appropriate for PONDIMIN therapy, please note the Warnings section has been revised to convey the final evaluation of the International Primary Pulmonary Hypertension Study, which examined the relationship between appetite suppressants and primary pulmonary hypertension (PPH).

PONDIMIN IS AN APPETITE SUPPRESSANT, AND APPETITE SUPPRESSANTS INCREASE THE RISK OF DEVELOPING PRIMARY PULMONARY HYPERTENSION, 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, a serious, potentially life-threatening cardiovascular condition. A 2-year case-control study identified 95 PPH cases; 30 of these had been exposed to appetite suppressants in the past, and 18 of the 30 had used appetite suppressants for longer than 3 months. Therefore, the risk associated with the long-term use of appetite suppressants was estimated to be about 23 to 46 cases per 1 million persons per year.

The most common side effects of PONDIMIN include drowsiness, diarrhea, and dry mouth. 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) a monoamine oxidase inhibitor. Patients with a history of drug abuse should not receive this drug. PONDIMIN should not be administered to patients with alcoholism and should be avoided in patients with psychotic illness. Potent anesthetic agents should be administered with caution in patients taking PONDIMIN. Other CNS-depressant drugs should also be used with caution in patients taking PONDIMIN. PONDIMIN is not recommended for pregnant or lactating women or for pediatric patients. The maximum recommended dose of PONDIMIN (120mg/day) should not be exceeded.

Concomitant use of PONDIMIN (fenfluramine HCl tablets) with other weight-loss agents is not recommended. The addition of phentermine to PONDIMIN ("fen/phen") is not an approved use of PONDIMIN. Potential safety concerns with the concomitant use of PONDIMIN and phentermine have not been systematically evaluated in large, multicenter, placebo-controlled trials. If you would like more information about PONDIMIN, please contact our medical information service at 1-800-934-5556.

Sincerely,

Marc W. Deitch, M.D.
Senior Vice President, Medical Affairs and Medical Director

Encl.

See accompanying Prescribing Information.

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