HEART AILMENT LINKED TO FEN-PHEN.

Byline: Angela La Voie Medical Tribune News Service

Fen-phen, the popular diet-drug combination, may increase a person's risk of valvular heart disease, according to Minnesota researchers who were granted a rare exception by the New England Journal of Medicine to announce their findings in advance of the Aug. 28 publication date.

The medical journal allowed the researchers to go public with their findings Tuesday at a news conference in Rochester, Minn., because of the potential public health implications, said Dr. Gregory Curfman, a deputy editor at the journal.

``I think the main thing we need to do is find out the extent of the problem,'' Curfman said. ``In the meantime, individual people need to make sensible decisions for themselves, realizing that there may be a new complication of fen-phen that we didn't know about before.''

The U.S. Food and Drug Administration also distributed a letter to physicians across the country warning them of the association of fen-phen with valvular heart disease and asking doctors to alert the FDA of any cases of the disease.

The condition results from a defect that prevents one of the heart valves from either opening or closing properly. It may lead to unsteady heartbeat, heart failure or heart attack, and often requires corrective surgery.

In the study, 24 Midwestern women with no previous history of heart disease were diagnosed with a defective heart valve after taking fen-phen for approximately six months to a year and a half, according to researchers led by Dr. Heidi Connolly, a cardiovascular consultant at the Mayo Clinic in Rochester, Minn. The women had all been treated by one of six Mayo Clinic doctors or a North Dakota doctor.

The FDA said it has received reports of an additional nine cases of valvular heart disease among fen-phen users.

Often touted as a wonder weight-loss aid, fen-phen is a combination of low doses of the appetite-suppressing drugs fenfluramine and phentermine. In 1996, the number of prescriptions for these drugs exceeded 18 million.

But the weight-loss combo has remained controversial because researchers have linked fenfluramine and its chemical cousin dexfenfluramine (sold as Redux) with a rare but potentially fatal lung condition called pulmonary hypertension, in which high blood pressure occurs within the arteries that supply blood to the lungs.

Among the 24 women in the study, eight of them also were diagnosed with pulmonary hypertension, Connolly said.

``Physicians who prescribe these medications should really evaluate their prescribing criteria and weigh the benefits of weight loss against the potential risks of valvular heart disease and pulmonary hypertension,'' she said.

``These are drugs that should be taken only by obese patients in conjunction with a weight-loss regimen that includes a reduced-calorie diet and an exercise program, in accordance with approved labeling,'' said Michael Friedman, lead deputy FDA commissioner.

More than one-third of the U.S. population is estimated to be obese. Obesity is a risk factor for illnesses that can lead to premature death, including diabetes, heart disease and some forms of cancer.

The Mayo Clinic study indicates the need for further investigation of the potential danger of using the fen-phen combination, said a representative of fenfluramine's marketer, Wyeth-Ayerst Laboratories, a division of Philadelphia-based American Home Products Corp.

``Although we are very concerned, these findings are clearly preliminary, and a comprehensive study is needed to confirm the association and determine its frequency,'' Connolly said.

In the meantime, people taking fen-phen should discuss the risks and benefits of the drugs with their doctor.

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