
DATE: Tuesday, September 16, 1997           TAG: 9709160266

SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: BY PAT DOOLEY, STAFF WRITER 

                                            LENGTH:  158 lines

DIET DRUGS PULLED AT FDA'S URGING MAKER CHOSE TO WITHDRAW PILLS LINKED TO HEART PROBLEMS

Two popular diet drugs became unavailable to consumers in Hampton Roads and elsewhere Monday, after their manufacturer voluntarily stopped sales at the request of the U.S. Food and Drug Administration.

The prescription-only drugs are dexfenfluramine, or Redux, and fenfluramine, half of the trendy combo dubbed fen-phen.

They have been used by some 50 million dieters, according to a recent report in the Journal of the American Medical Association.

The FDA said it was acting on growing evidence of ``significant side effects,'' including heart-valve disease in 24 fen-phen users whose cases were examined by the Mayo Clinic in Rochester, Minn., in July.

All two dozen patients had been healthy before using fen-phen for about a year. Some developed valve problems requiring surgery; none died.

Phentermine, the other half of the fen-phen combination, was not included in Monday's withdrawal. It has not been associated with heart-valve problems and still may be prescribed, said Peter Martineau, an FDA spokesman.

Phentermine and fenfluramine each received FDA approval as weight-loss aids more than 20 years ago. They had never been recommended for use in tandem. But, in recent years, doctors began combining them and reporting heightened results.

About 18 million prescriptions are written annually for the combination drugs, the FDA estimates.

Dexfenfluramine received FDA approval in April 1996. But earlier this year, reports began to surface of connections to a heart and lung condition called primary pulmonary hypertension. In recent months, dexfenfluramine also has been associated with heart-valve disease, said the FDA's Martineau.

More than 100 cases of heart-valve disease linked to fenfluramine and dexfenfluramine have been reported to the FDA since the Mayo report. Most of the patients reported symptoms, including shortness of breath, tiredness, faintness and swelling of the legs.

In the last two weeks, evidence against fenfluramine and dexfenfluramine mounted, the FDA said. Five physicians who performed echocardiograms of 291 patients using the drugs found abnormal heart valves in 30 percent of them. The patients had no symptoms of the disease.

The FDA recommends people stop using the drugs - which are no longer available in pharmacies - and consult their physician. American Home Products Corp. makes fenfluramine under the brand name Pondimin. Its subsidiary, Wyeth-Ayerst Laboratories, makes dexfenfluramine, or Redux.

Dr. Lisa Harris, an obesity specialist with offices in Chesapeake and Virginia Beach, is advising her patients to taper off the drugs.

Abruptly discontinuing them could cause sleep disturbances, depressed mood or other temporary difficulties, said Harris, one of Virginia's two board-certified specialists in bariatrics, the study of obesity.

Harris treats about 2,000 patients. As of Monday, about 15 were using dexfenfluramine, and 200 were using fen-phen.

She had received only two calls from patients as of midday Monday and was drafting a letter to others, explaining the FDA action and how they should stop using the drugs.

Many of her patients have been using phentermine only, with good results, Harris said.

Fenfluramine and dexfenfluramine are believed to diminish carbohydrate cravings by increasing the brain's supply of the neurotransmitter serotonin. Phentermine produces a ``more generalized curbing of cravings,'' by affecting the availability of the neurotransmitter noradrenaline, Harris said.

Other drugs that affect noradrenaline are still available to dieters, said Dr. Denise E. Bruner, Virginia's other bariatrics specialist and vice president for the 1,500-member American Society of Bariatrics Physicians. They include mazindol and diethylpropion.

Bruner, who treats about 800 patients from her office in Arlington, has prescribed phentermine for about 16 years, with good results. She added fenfluramine in 1992, at the request of patients, but in doses at less than half the norm, she said.

Since last year, she has prescribed dexfenfluramine, also in low doses.

About 20 percent of her patients used weight-loss drugs as of Monday, she said.

Like other bariatrics specialists, Bruner believes obesity must be treated through a variety of methods, including nutrition and exercise counseling.

``It's not like having an infection,'' she said.

The drugs were designed for people who are 20 percent or more over their ideal weight - whose condition puts them at serious risk for other diseases, including diabetes and heart attack, Bruner said.

She and others charge that the drugs have been overprescribed, often doled out to recreational dieters who wanted to lose 5 or 10 pounds.

``Everybody in the world has been prescribing these without a comprehensive program,'' Bruner said.

``Doctors started passing them out like candy.''

The FDA's action, she said, simply points out the fact that, at least for now, there is no magic pill.

Linda Chapman-Wessel, an advertising executive in Charlottesville, lost more than 40 pounds using fen-phen for about 15 months.

The only problem she experienced was with short-term memory loss, she said. Sometimes, in a rush, for example, she'd go to dial a familiar phone number but couldn't remember it.

Chapman-Wessel consulted with her doctor and switched to phentermine about six weeks ago, as negative reports about the other drugs increased, she said.

Since then, she has lost another 3 or 4 pounds but believes weight loss requires more than a pill. It also means commitment to lifestyle and dietary changes and frequent visits to a physician, she said.

``There is no quick-fix drug,'' she said.

The FDA has not recommended an echocardiogram - an ultrasound image of the heart pumping - for everyone who has used fen-phen or dexfenfluramine. But it suggests anyone who is concerned or experiencing symptoms consult their physician.

FDA spokesman Martineau said he didn't know whether the drugs would ever return to the market. Doctors have been asked to continue reporting problems to the FDA's MedWatch.

It also is not yet known if the heart-valve disease is reversible, Martineau said. Treatment can include medication to help the heart function properly, or surgery.

``Herbal Phen-Fen,'' which is sold over-the-counter in some fitness and health-food stores, is not affected by Monday's action. It does not contain fenfluramine, dexfenfluramine or phentermine.

However, Herbal Phen-Fen and some similar over-the-counter products contain ephedra, a heart and nervous system stimulant linked with more than 800 illnesses and about 40 deaths in the United States since 1994.

The FDA recently proposed new guidelines for products containing ephedra and urged consumers to be cautious. ILLUSTRATION: Color photo

ASSOCIATED PRESS/file

The diet combo fen-phen contains the prescription drugs fenfluramine

- which has been voluntarily withdrawn - and phentermine.

Graphics

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