
DATE: Friday, November 14, 1997             TAG: 9711140625

SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: BY PAT DOOLEY, STAFF WRITER 

                                            LENGTH:  129 lines

PAST USERS OF 2 DIET DRUGS SHOULD SEE DOCTOR, FDA SAYS

Anyone who used either of two prescription diet drugs recently pulled from the market should see a doctor to rule out possible heart problems, the federal government said Thursday.

The drugs - dexfenfluramine, or Redux, and fenfluramine, half of the popular combination dubbed ``fen-phen'' - were voluntarily withdrawn by their manufacturer in September after some people who used them developed heart-valve disease.

The U.S. Food and Drug Administration now advises that people who used the drugs ``for any period of time, either alone or in combination with other agents, undergo a careful medical history and a cardiovascular examination by their physician.''

After the drugs were withdrawn, the agency suggested that people experiencing symptoms of heart-valve disease - shortness of breath, weakness, swelling - have an echocardiogram done, which is an ultrasound image of the working heart. But now the agency advises everyone who used the drugs to visit their doctor - even if they feel fine.

The change, said FDA spokesman Peter Martineau, is a response to continued questions from consumers who seem confused about what they should do if they've used the drugs. It does not reflect new information concerning problems with the drugs, he said.

``So many people are coming back and asking for direction,'' Martineau said Thursday.

As before, the agency advises people with symptoms of heart or lung disease to obtain an echocardiogram.

But now it also recommends the test for anyone who has used the drugs and is planning to have invasive surgery or dental work that may involve bleeding.

A person with heart-valve disease would be at increased risk for bacterial endocarditis, a potentially fatal infection of the heart's lining caused by bacteria getting into the bloodstream.

Surgical or dental patients with significant heart-valve disease may need antibiotic treatment before a procedure, the FDA said.

Studies reported to the FDA show that for unknown reasons about one-third of patients exposed to fenfluramine or dexfenfluramine have heart-valve damage. The condition can cause a backward flow of blood into the heart and can be fatal.

The recommendations, issued by the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, appear in today's Morbidity and Mortality Weekly Report by the CDC.

Dr. Lisa Harris, one of Virginia's two board-certified specialists in obesity, called the recommendations ``prudent, good medicine.''

But Harris, who had prescribed fen-phen for about 200 of her 2,000 patients and Redux for 15 or 20, said none of them has been found to suffer from heart-valve disease.

When patients come to her weight-loss clinics in Virginia Beach and Chesapeake, she listens to their hearts with a stethoscope. A new heart murmur, for example, might indicate a problem with valve damage. ``I haven't detected any murmurs,'' Harris said.

However, in accordance with previous FDA recommendations, Harris had not suggested all her patients who used the drugs see her for a cardiac examination.

After the diet drugs were withdrawn, Harris wrote to her patients, suggesting that anyone with symptoms or concerns see her or their primary-care physician to determine if an echocardiogram was needed.

Now, Harris said, she will send letters again, telling anyone who's used the drugs see her or another physician for signs of a new heart murmur or other problems.

As with the federal agencies, Harris said many people have called her, asking what to do.

``People are concerned,'' she said. ``But I wouldn't say I've had anybody frightened.''

A few even have told her they would resume the drugs immediately if they were permitted to buy them. Some had lost as many as 60 pounds while using the drugs.

``Several patients have hoarded the medicine,'' Harris said of fenfluramine and dexfenfluramine. She warns them not to take it. ``They've hoarded it, and they've gotten it from other people who stopped taking it.''

Other drugs, such as phentermine, the other half of fen-phen, still are available. But results appear less impressive, many experts say.

The FDA called Thursday's guidelines ``interim,'' saying they are based on current knowledge and may change.

The agency issued its first public advisory about fen-phen in July, after doctors at the Mayo Clinic in Rochester, Minn., reported that 24 women who had used the combination for about a year developed heart-valve disease. The patients, some in their 20s, did not have signs of the disease before using the drugs.

Later, a five-physician study of people using fen-phen showed nearly a third of 291 patients had developed heart-valve disease but had no symptoms. It is not known if the condition is reversible.

Redux, already associated with a potentially fatal lung condition called primary pulmonary hypertension, was also connected with heart-valve problems.

In July, the FDA sent letters to 700,000 healthcare providers, requesting information on patients who developed similar problems and had used the drugs.

As of Sept. 30, the FDA had received reports of 144 provider-initiated cases of valve problems involving the drugs.

Fenfluramine and phentermine were approved for weight loss more than 20 years ago. The FDA never advised using them together. Physicians started prescribing them in tandem about five years ago, after one study showed the ``off-label use'' improved dieters' results.

The FDA approved Redux, or dexfenfluramine, for weight loss in April 1996. The drug's labeling, however, stated that safety had not been shown for more than a year of use. Redux had been used in Europe for more than a decade without reported associations with heart-valve disease, the FDA said.

Earlier this month, the FDA also warned consumers about the proliferation of herbal alternatives to the diet drugs. Some, such as ``Herbal Phen-Fen,'' do not contain either of the withdrawn drugs but do contain ephedra, a heart and nervous-system stimulant linked to more than 800 illnesses and about 40 deaths in the United States since 1994. ILLUSTRATION: Graphic

ABOUT ECHOCARDIOGRAMS

What is an echocardiogram?

It is a picture of the working heart, the same procedure as the

ultrasound examination used to check the growth of the fetus in a

pregnant woman.

What's next if I have heart-valve problems?

Based on current data, many patients don't require treatment

other than careful follow-up by their doctor. Some patients do

develop signs of heart disease, such as chest pain, shortness of

breath or heart palpitations. Some patients may be referred to a

cardiologist. Researchers are trying to learn if the valve problems

associated with the withdrawn diet drugs tend to diminish or worsen