December 1996

Dear Health Care Professional:

I am enclosing the revised REDUX (dexfenfluramine HCl capsules) C-IV product labeling, which I recommend that you review. This labeling reflects the information communicated to you in my letter of last August. The Warnings section was 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). The data describing this relationship are as described in my last letter to you.

The patient counseling provided by you and your colleagues plays an extremely important role in the success of any therapy. In the case of REDUX, your counseling can help patients understand the risks and benefits of REDUX therapy. To help in that counseling, I have enclosed copies of "Important Patient Information" sheets. These information sheets are included in the REDUX starter kit, a packet containing diet, exercise, and product information, which you have been providing to new REDUX patients. The sheets are also available through pharmacists and are being affixed to the REDUX packaging as a Patient Package Insert. Additional copies are available through your Wyeth-Ayerst sales representative or by calling the Wyeth-Ayerst medical information line at 1-800-934-5556.

As you know, REDUX is indicated for weight loss and maintenance of weight loss in patients on a reduced-calorie diet who have an initial body mass index greater or equal to 30 kg/m2 (at least 30% over ideal weight) or greater or equal to 27 kg/m2 (at least 20% over ideal weight) in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). The safety and effectiveness of REDUX beyond 1 year have not been determined.

REDUX 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.

In animals receiving high doses of dexfenfluramine for short periods of time that resulted in brain concentrations approximately 10 times those seen in humans, neurochemical changes were observed. These changes were generally reversed over time but persisted for over a year in one study of three animals. The importance of these findings to humans is not known.

The most commonly reported side effects include diarrhea, dry mouth, and somnolence. Redux (dexfenfluramine HCl capsules) should not be used in patients with hypersensitivity to dexfenfluramine or related compounds or in patients with diagnosed pulmonary hypertension. REDUX should not be used concomitantly with a MAO inhibitor or within 14 days of discontinuation. REDUX should not be taken in combination with other selective serotonin reuptake inhibitors. REDUX is not recommended for pregnant or nursing women or people under 18 years of age.

Sincerely,

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

Encl.

See enclosed full Prescribing Information.

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