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The diet drugs Fen-Phen (fenfluramine and
phentermine), Pondimin (fenfluramine), and
Redux (dexfenfluramine) aid in weight loss
by altering the serotonin levels in the brain
to suppress feelings of hunger.
During the 1990s, doctors began to prescribe
these drugs in combination to increase the
weight loss effect. Studies have demonstrated
serious potential health risks associated
with the use of these drugs. These findings
were so serious that the Food and Drug Administration
(FDA) withdrew Fen-Phen and Redux from the
market in 1997.
Problems associated with the use of these
diet drugs include:
*
serious heart murmurs,
* heart valve leaks,
* thickening of the heart valves, and
* heart valve regurgitation, which is a build-up
of a plaque-like substance on the heart valves.
A 1997 report from the Mayo Clinic found heart
valve dysfunction in 30% of Fen-Phen users
who were tested. Another severe side effect
of Fen-Phen is PPH. Lawsuits previously filed
state that some manufacturers and distributors
were aware of the health risks associated
with these drugs and failed to adequately
warn of such risks.
The rare and serious condition known as primary
pulmonary hypertension (PPH) affects the arteries
within the lungs. The illness can be fatal
and progresses over time. The condition begins
when tiny arteries in the lungs become narrow
or blocked, causing increased resistance to
blood flow in the lungs, which then raises
pressure within the pulmonary arteries.
As the pressure builds, the right ventricle
of the heart must work harder to pump blood
through the lungs, eventually causing the
heart muscle to weaken and sometimes to fail
completely. There is presently no cure for
PPH, but drug treatments can help lessen symptoms
and improve quality of life for many people.
The FDA, along with the Centers for Disease
Control and the National Institutes of Health,
recommend that anyone who has ever taken either
Redux or Fen-Phen alone or with other diet
drug medications, should see their doctor
immediately for a physical examination to
determine if any heart or lung damage has
occurred -- even if no symptoms are apparent.
Fen-Phen and Redux Withdrawn from
Market
On September 15, 1997, at the request of the
US Food and Drug Administration, American
Home Products withdrew Fen-Phen and Redux
from the market. This followed reports that
heart-valve abnormalities were found in 30%
of Fen-Phen users who were given diagnostic
echocardiograms at the Mayo Clinic. Additional
studies also indicated that Fen-Phen caused
the potentially fatal lung disease, Primary
Pulmonary Hypertension (PPH), in some patients
taking the drugs.
Studies have estimated that using Fen-Phen
increases a person's chances of developing
PPH by approximately 30 percent. It has been
suggested by medical professionals that the
last dose of Fen-Phen having been digested
may still be a risk for nearly ten years following.
Fen-Phen and Redux Class Action
The occurrence of heart valve-related health
problems associated with the use of Fen-Phen
and Redux resulted in a National Class Action
Settlement with American Home Products Corp.
(AHP), now known as Wyeth, the manufacturer
of these diet drugs. The Settlement received
final Judicial Approval on January 3, 2002,
triggering a number of deadlines.
Those who have not opted-out or withdrawn
from the settlement and who have consumed
one of the three controversial weight loss
supplements will be automatically apart of
the settlement. In order to be eligible for
certain benefits, you must first register
and you must have an echocardiogram (a non-invasive
ultrasound of the heart). Those who have previously
met the requirements for Matrix level benefits
of the heart valve damage have the potential
to receive monetary compensation that may
near $1.4 million.
It is also important to note that the Settlement
does not cover or provide benefits to persons
diagnosed with PPH. These individuals can
proceed with individual lawsuits against Wyeth
if they meet the criteria for PPH, as defined
in the Settlement program.
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