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In
1997 the FDA asked American Home Products, the makers of Pondimin (Fenfluramine)
and Redux (Dexfenfluramine), to withdraw it's popular anti-obessity drugs
from the market. American Home Products Corp. of Madison, N.J.,
manufactured fenfluramine under the brand name Pondimin
and a American Home Product's subsidiary Wyeth-Ayerst Laboratories,
manufactured Dexfenfluramine for Interneuron Pharmaceuticals, which was
marketed under the name of Redux.
Medical studies have linked Pondimin or Redux to heart valve disease.
The FDA
stated that in findings from doctors who evaluated patients that took
Fenfluramine and Dexfenfluramine, with echocardiograms, that approximately
30 percent of patients who were evaluated had abnormal echocardiograms,
even though they had no symptoms. This is a much higher than expected
percentage of abnormal test results.
Additionally a Mayo Clinic study that was published in the New England
Journal of Medicine on August 28, 1997 suggested that as high as one-third
of a patient sampling of Fen-Phen diet pill users had evidence of heart
valve disease. The study found that there was a high incidence of heart
valve disease in patients taking these diet pills, without any other known
reason for valve disease.
In addition to heart valve disease the use of fenfluramine and
dexfenfluramine has been found to increase the risk of developing Primary
Pulmonary Hypertension or (PPH). PPH is a rare disease of that causes the
progressive narrowing of the blood vessels of the lungs. Studies estimate
that treatment with certain appetite suppressant drugs tends to increase
the chances of developing PPH by approximately 25 to 30 percent.
Medical reports have also linked Pondimin (fenfluramine hydrochloride) to
the occurrence of serious regurgitant cardiac valvular disease, including
disease of the mitral, aortic, and/or tricuspid valves. In one medical
study, 24 patients, who received combination therapy with fenfluramine and
phentermine for treatment of obesity, were found to have regurgitant
cardiac valvular disease; five of these patients required valvular
surgery. There have also been reports that taking fenfluramine alone can
cause valvular disease.
In 1999, American Home Products agreed to pay as much as $3.75 billion to
settle lawsuits over its Redux and Pondimin diet drugs, in what would be a
record injury settlement involving a pharmaceuticals company. The
agreement would provide benefits, ranging from drug refunds to injury
payments of as much as $1.4 million a person, for the six million or so
people who took the drugs. However, many victims and lawyers don't feel
the settlement was far reaching enough, as it left out thousands of
injuries.
If
you believe you or a loved one have been injured by Fen-Phen, please fill
out and submit our Case
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