THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Saturday, June 22, 1996 TAG: 9606220245
SECTION: BUSINESS PAGE: D1 EDITION: FINAL
SOURCE: BY PAT DOOLEY, STAFF WRITER
LENGTH: 100 lines
Pharmacists in Hampton Roads say interest is high in a new weight-loss drug that appeared in drugstores a week ago.
Consumers are asking about the prescription-only pill, designed to fight obesity. Called Redux, it is the first weight-loss drug approved by the U.S. Food and Drug Administration in more than 20 years.
``It just came in and we have already exhausted our supply,'' said Larry Payne, pharmacist at the Linkhorn Plaza Revco in Virginia Beach.
At Atrium Pharmacy in Norfolk, about 100 people have asked for information in the last few weeks, said Jay Levine, pharmacist and co-host for WHRV-FM radio's ``The Pharmacy Report.''
Redux, or dexfenfluramine hydrochloride, works by increasing the brain chemical serotonin, which helps to give feelings of fullness. It is similar to other newly popular weight-loss drugs: fenfluramine, phentermine, and ``fen-phen,'' a combination of the two. The drugs are not designed for casual weight loss but for the treatment of obesity - defined as 30 percent over ideal weight.
The FDA approved fenfluramine and phentermine in 1973, but not as a combination. Because research shows the drugs in tandem are more effective for a portion of dieters, some doctors prescribe them together.
Dr. Lisa Harris, of Chase Wellness Center in Chesapeake, is among them.
A handful of her patients use Redux, which she received in advance of drugstores after the FDA approved it in April.
In studies, Redux showed fewer side effects than other weight-loss pills. Drowsiness, diarrhea and dry mouth are most common. A rare but potentially life-threatening cardiovascular condition, primary pulmonary hypertension, also is associated with Redux and other weight-loss drugs.
The FDA considers Redux safe, when monitored closely. But the long-term effects are not clear because clinical trials involving 900 dieters spanned only one year.
The manufacturer, Wyeth-Ayerst Laboratories, promotes Redux for weight-loss and its maintenance. But, Wyeth's literature states, ``the safety and effectiveness of Redux beyond one year have not been determined.''
Redux and similar drugs are ``amphetamine-like,'' but are not classified as potent stimulants or as habit-forming, said Dr. Warren Koontz, executive director of Virginia's Board of Medicine.
Still, the board is cautious because members see a potential for abuse.
It is reviewing its regulations concerning how long weight-loss drugs should be prescribed. At issue is the definition of ``short-term use,'' which the board recommends as 90 days, before more medicine is prescribed.
If approved, the regulation could go into effect this fall, Koontz said.
Because the long-term effects of the drugs are unknown, some patients also are concerned. But obesity carries its own risks - heart disease, high cholesterol, hypertension - and a stigma that bruises self-esteem.
``It's not easy to bend down and tie your shoes,'' said Linda Mitchell, a Chesapeake resident who's battled obesity most of her life. ``Clothes don't feel good. You don't feel good about yourself.''
Over the years, Mitchell, 53, has dieted, joined weight-loss clubs, and even had her jaw wired shut. The weight returned, and then some - 32 pounds in the last couple of years.
A regional director for FischerMangold, a Virginia Beach firm that staffs and manages emergency departments, Mitchell was frustrated by her inability to maintain weight loss.
After consulting with Harris, she began a fen-phen regimen, exercise and healthful eating - and lost about 20 pounds in seven weeks. She recently switched to Redux, which, for her, has fewer side effects.
Redux doesn't work alone, Mitchell said, but it gives her more control over cravings. ``This allows you to diet,'' she said.
While Mitchell might like to take Redux for life, she doesn't know if that is prudent. Still, she hopes her new habits will help her keep off the weight, even without the drug.
``I'm happy that the medicine is there,'' she said, ``and that there is hope.'' ILLUSTRATION: Graphic
ABOUT REDUX
What is it? Redux is the brand name for dexfenfluramine
hydrochloride, a new drug for the treatment of obesity and
weight-loss management.
How does it work? Dexfenfluramine raises the level of a brain
chemical called serotonin, which helps to create feelings of
fullness or satisfaction.
Who can use it? People who are at least 30 percent over ideal
body weight. It also can be used by people who are 20 percent over
ideal weight, if there are other risk factors such as high-blood
pressure or diabetes.
What are the side effects? Most common are dry mouth, diarrhea
and drowsiness. In clinical trials, the symptoms were mild and
usually disappeared within a few weeks. Redux also is associated
with primary pulmonary hypertension, a rare but potentially fatal
cardiovascular condition.
Who shouldn't use it? Patients using other serotonin-type drugs
or monoamine oxidase (MAO) inhibitors; pregnant or nursing women;
children; people with pulmonary hypertension.
What does it cost? About $60 to $70 a month. Patients take two
15-milligram capsules daily.
Who makes it? Wyeth-Ayerst Laboratories, Philadelphia. The
company also makes fenfluramine, a similar drug used to treat
obesity.
KEYWORDS: WEIGHT-LOSS PRODUCTS DRUGS by CNB