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The
History of fen-phen
Back
in 1984, a study was published that indicated that phentermine
and pondimin (fenfluramine), if used in low dose combination
with one another, could achieve weight loss with fewer side
effects than when taking one or the other. Both drugs had
previously been used separately for the purpose of appetite
control. The diet industry began developing a revolutionary
combination drug, what we now know as fen-phen, which would
have significant result for weight loss. One 1992 study found
that 120 obese patients being treated with fen-phen lost an
average of 30 pounds. Pondimin and redux were originally approved
for short-term use by the FDA for the treatment of obesity.
Fen-phen had never been approved.
Finally,
in 1995, redux, the weight loss drug developed by Professor
Richard Wurtman was given approval to be marketed in the United
States. When fen-phen hit the market, users reported stunning
results. As the American public flocked to this new weight
loss drug, physicians and weight-loss centers adopted fen-phen
as a safe and effective answer for many of their patient’s
weight problems. This new "miracle weight loss answer"
was prescribed to a large spectrum of individuals, from the
obese to those who were trying to shed 5 or 10 pounds. During
its first year of mass marketing (1996) some six million Americans
used the drug fen-phen to lose weight. It is estimated that
more than 17 million prescriptions for fen-phen were written
in 1996.
The
fen-phen miracle cure came to an end when, in the summer of
1997, the Mayo Clinic released a study that stated that fen-phen
caused serious side effects. Principal among these was heart
valve defects. In fact, the study showed that as many as one-third
of the patients who used fen-phen diet pill had evidence of
heart valve disease. Specifically, the drug caused defects
in the aortic and mitral valves that resulted in blood being
regurgitated into the ventricle and left atrium. This condition
was potentially very serious, and cause for concern.
FDA
Recalls fen-phen
On
July 8, 1997, the FDA issued a warning regarding the heart
valve problems associated with the usage of redux and pondimin.
The very next month the FDA notified doctors and drug makers
to withdraw fenfluramine and redux from the market. The makers
of pondimin (fenfluramine) and redux (dexfenfluramine) decided
it was in their best interests to voluntarily withdrew the
drugs from the market.
In
November of 1997, the FDA took a further precautionary step
by recommending that anyone who has used fen-phen or dexfenfluramine
undergo a medical examination even if they displayed none
of the apparent side effects.
The
high profile publicity of the Mayo study and the FDA’s call
for a voluntary recall from the market was accompanied by
individuals coming forth to relate the medical complications
they experienced from the use of fen-phen. Fen-phen is currently
off the market and will probably never be approved for future
public use.
If
you or someone you know has a health risk associated with
fen-phen, you’re entitled to know your legal rights.
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