buyhiman, Here's another article on Redux and phen/fen. It acknowledges that Redux is used alone and even breaks out the fact that 270 of the 291 patients who showed the abnormal EKG were on phen/fen for 6 months to a year (thus the IPIC press release was probably read by the author). However, it fails to note that 2/6 on Redux alone had abnormal EKGs:
Diet Drug Recall Tied to Heart Damage
Risk
By RICHARD A. KNOX
c.1997 The Boston Globe
New evidence on America's most popular diet pills raises the
disquieting possibility that tens of thousands of patients may have
suffered silent heart valve damage from taking them, federal officials
and medical researchers said Monday.
The data, received this month by the US Food and Drug
Administration, go considerably beyond earlier reports that dealt only
with symptomatic heart disease and death among users of the diet
drugs Redux and Pondimin. In response to the new findings, gathered
from five different research sites, the drugs' manufacturers withdrew
them from the market Monday.
It is not yet clear whether the asymptomatic heart damage is
permanent and likely to worsen over time, or reversible once the drugs
are stopped.
Redux, known generically as dexfenfluramine, is taken alone. But most
of the patients with unsuspected heart valve damage were taking the
popular but unapproved combination called ``fen/phen,'' which
involves Pondimin, or fenfluramine, along with phentermine.
Phentermine remains on the market. But, faced with the new evidence
last Friday, the drugs' manufacturers, American Home Products Corp.
and its subsidiary Wyeth-Ayerst Laboratories, agreed to withdraw
Redux and Pondimin.
The action was based on data documenting asymptomatic heart valve
problems among one-third of patients taking one or the other drug for
weight loss.
The 30 percent damage rate ``is a much higher than expected
percentage of abnormal test results,'' than earlier reports last summer
and last year suggested, the FDA said. Those had focused only on
less common symptomatic side effects with the drugs - more severe
valvular damage, pulmonary hypertension and death. The agency said
Redux and Pondimin now ``present an unacceptable risk'' to patients.
The new evidence consists of mild to moderate valve damage -
backward leakage of blood through the aortic and mitral valves. FDA
officials and doctors familiar with the data say no one knows whether
this damage will worsen or reverse itself once patients stop taking
Pondimin or Redux.
Dr. Jack L. Crary, a North Dakota doctor who discovered 19 of 24
patients with more severe heart valve problems from diet drug use
reported in July with Mayo Clinic researchers, said the new data
indicate a higher rate of problems than he expected. ``From the
beginning we wondered how many unsuspected cases were out
there,'' Crary said. ``We tried not to be alarmist in our report, but this
certainly is worrisome.''
``The moral of this story is that there was a lot of indiscriminate use of
these drugs,'' added Dr. Frank Silvestry, a University of Pennsylvania
heart specialist who submitted data to the FDA this month with
colleague Dr. Thomas Wadden. ``I hope this won't turn to be an
epidemic of important valve diseases in these patients.''
Other new evidence comes from individual doctors, clinics and
academic medical centers in Milwaukee; Minneapolis; Naples, Fla.;
and Danville, Ind.
The FDA is not calling for the withdrawal of phentermine, the other
half of the ``fen/phen'' combination.
American Home Products Corp. agreed to withdraw the drugs after
seeing the new FDA data on Friday. ``Even though this new
information is not derived from a thorough clinical study and is difficult
to evaluate, the company is taking the most prudent course,'' said Dr.
Marc W. Deitch, a Wyeth-Ayerst vice president.
The French manufacturer of fenfluramine and dexfenfluramine also
pulled the drugs from the market Monday.
The FDA urged patients to stop taking Redux or Pondimin
immediately and consult their primary physicians. However, some
doctors said the drug dose should be tapered over a week or so
under a physician's guidance.
Of the 291 patients tested for heart valve damage by an ultrasound
device called an echocardiogram, 92 had evidence of valve damage.
Among the total group, 270 had been taking the unapproved
``fen/phen'' combination for six months to more than a year, an FDA
official said Monday in an interview.
Dr. Janet Woodcock, director of the agency's Center for Drug
Evaluation and Research, said it is possible that several hundred
thousand Americans may have suffered similar damage without
knowing it. Without an echocardiogram, their doctors wouldn't know
it either, since the mild to moderate damage seen among patients
screened so far produces no symptoms or physical clues, such as a
heart murmur.
The FDA tentatively estimates that 1 million Americans have used the
fen/phen drug regimen, whose advocates say helps many people lose
weight by blunting their craving for carbohydrates. The FDA has never
approved the fen/phen regimen, but that has not stopped thousands of
doctors and weight-loss clinics from pushing it as the latest in diet
therapy.
``We don't know yet if we can extrapolate'' the 30 percent rate of
heart valve problems ``to the general population who were exposed,''
Woodcock said. ``Maybe in a few weeks we'll have a better idea.''
Woodcock said the FDA plans to evaluate more echocardiograms
from patients who have been taking fen/phen or Redux to verify if 30
percent have unsuspected programs.
The agency also wants some patients with silent valve damage to have
serial echocardiograms to see if the problem worsens or improves
over time. ``We have one report in which the valvular problem in a
single patient improved after several months off therapy, but we don't
know how to interpret that,'' Woodcock said.
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(The Boston Globe web site is at globe.com )
NYT-09-16-97 1006EDT< |
