March, 1997

This letter is intended to clarify and place in proper perspective information concerning primary pulmonary hypertension which has recently been highly publicized in the news media. Primary pulmonary hypertension (PPH) is a potentially serious disorder in which an association has been established with long term use of anorectic agents (Phen/Fen and Redux). Patients with this rare disorder develop congestive heart failure and have a survival rate of 55% at four years. There are no patient profiles to help a physician determine who might be more predisposed to PPH; and no current practical studies to evaluate increasing pulmonary artery pressure as an aid for diagnosis. Symptoms of dyspnea (shortness of breath), decreased exercise tolerance, chest pain, edema of the lower extremities and syncope (fainting) require further evaluation.

The facts and statistics concerning the potential risk of developing the pph are as follows:

A recent editorial from the New England Journal of Medicine (December 1996) estimated about 28 cases/million person years of exposure (1 in 40,000 patients). This is about equal to the risk of a woman on birth control pills having a fatal pulmonary embolus (blood clot in the lungs) or a patient receiving penicillin and dying from an acute anaphylactic reaction. In twenty-five years as a family practice physican, including eight years as an emergency room physician, I never had a patient with either of these unfortunate medical outcomes. The recent death of a woman in Massachusetts (February 1997), if determined to be associated with the use of Phen/Fen or Redux, would be the first documented case in this country in the past fourteen months.

A recent two year European study identified ninety-five PPH cases of which twenty of these had been exposed to anorectic agents (Phen/Fen or Redux) within the past year, and nine of the twenty had been exposed to anorexigens for greater than 3 months. In the other 75 cases anorectic agents were not involved. In the world literature since 1981, there have been only thirty-seven cases of PPH associated with anorectic usage. The benefit to risk ratio is estimated to be at least 20:1 (280 lives saved as compared with 14 deaths caused by the drugs per million person-years of treatment). In this country 300,000 people will die this year from complications and diseases related to obesity; nine thousand people will die from food poisoning and almost four times as many women will die from pregnancy related complications. Statistically, one has a greater chance of being struck by lighting than developing PPH.

I hope this information will be useful to you concerning this potentially serious but rare disorder.


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