FDA PULLS 2 DIET PILLS FROM MARKET
Tuesday, September 16, 1997
; Page A1
WASHINGTON (AP) - Two of the nation's most popular diet drugs were pulled
off the market Monday after the government uncovered disturbing new evidence
that they could seriously damage patients' hearts.
The Food and Drug Administration urged millions of dieters to immediately
stop taking Redux, also known as dexfenfluramine, and Pondimin, also known as
Pondimin is one-half of the wildly popular fen-phen diet combination; the
other half, phentermine, appears safe when used by itself, the FDA said.
But doctors said phentermine, the sole remaining prescription diet drug,
has only mixed results - and they predicted a surge of patients distraught
both at the possibility their hearts were damaged and at losing their
"We are anticipating lots of very desperate patients that need help," said
Dr. John Foreyt, an obesity expert at Baylor College of Medicine.
"Obesity does kill," said Dr. Richard Atkinson of the American Obesity
Association, who said many Redux and Pondimin users will regain their weight.
The FDA asked Wyeth-Ayerst Laboratories, which sells Redux here and whose
parent company makes Pondimin, to withdraw the drugs because of new evidence
that they damage heart valves, and the firm agreed.
The U.S. decision prompted the French company, Servier, that sells
fenfluramine and dexfenfluramine abroad to withdraw the drugs worldwide.
The FDA had been struggling to determine the drugs' risk since it and the
Mayo Clinic uncovered the first cases in July. Last week, the FDA analyzed
heart tests on 291 dieters and found almost a third - 92 people - had damaged
heart valves, even though they had no symptoms.
That's much higher than anticipated. Less than 1 percent of the general
population has such damage to their aortic or mitral valves, said Dr. Richard
Bowen of Naples, Fla., who tested 200 of the patients.
Most of the valves leaked blood, a condition that over time can enlarge the
heart and seriously weaken it.
Also, the FDA analyzed 25 patients who happened to have had their hearts
tested before ever taking diet pills - and after taking the pills, about a
third were newly diagnosed with valve damage.
Those patients are in addition to 99 other fenfluramine or Redux users
whose doctors have reported to FDA actual symptoms of heart damage, such as
shortness of breath, chest pain or swollen ankles. Three of them died, and 17
underwent heart surgery.
The newest findings show the drugs "present an unacceptable risk," said FDA
Acting Commissioner Dr. Michael Friedman.
Wyeth-Ayerst's Dr. Marc Deitch called the withdrawal "the most prudent
course of action." But he said there is still not definitive proof that the
drugs are to blame, and said Wyeth-Ayerst will within a few weeks begin
studying whether obese people are naturally more prone to valve disease.
Meanwhile, dieters can return unused portions of the drugs for a refund.
Dieters should see their doctors for close heart monitoring, Atkinson said.
But not everyone will need an echocardiogram, a sophisticated test that shows
heart function and costs between $500 and $1,000, he cautioned.
The FDA said no one knows whether patients' valve leakage will heal once
they stop the drugs. But Florida's Bowen said three of his severe patients did
heal, and urged dieters not to rush into heart surgery.
The FDA's first warnings in July caused diet prescriptions to plunge, and
earlier this month, Florida banned prescriptions of the fen-phen combination,
and lawsuits have been filed over the drugs.
Still, Wyeth-Ayerst says 2 million Americans have taken Redux since it hit
the market in June 1996, and 4 million have taken Pondimin since 1973, most in
recent years. Critics have charged that too many people risked taking the
drugs just to lose a few pounds, not because they were truly obese.
Diet and exercise still are the best treatments, said FDA's Friedman.
"These medications have never been by themselves ways of simply and
permanently having people lose weight," he said.
But the obese now will have few medical options. Some doctors say
phentermine, the other half of fen-phen, works very well on its own while
other physicians disagree.
So-called "herbal fen-phen," dietary supplements that contain the chemical
ephedrine, are not safe alternatives, Atkinson said - and a pending FDA
proposal would ban them.
Patients can call 800-892-2718 for more information.
Articles appear as they were originally printed in The Telegraph Herald and may not include subsequent corrections.
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