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In 1997,
the FDA asked American Home Products Corporation, the makers of
Pondimin® (fenfluramine) and Redux™ (dexfenfluramine),
to withdraw it's popular diet drugs from the market. American Home
Products Corporation of Madison, New Jersey, manufactured fenfluramine
under the brand name Pondimin® and the 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® and Redux™
to heart valve and other medical problems.
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 drug 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.
The two
most common heart valve disorders are aortic valve regurgitation
and mitral valve regurgitation. Aortic valve regurgitation and mitral
valve regurgitation occur when the aortic and mitral valves are
damaged or not working properly.
Heart
valves help blood flow in only one direction as it moves between
different chambers of the heart and into and out of the heart. Aortic
valve regurgitation occurs when the flaps of the aortic heart valve
do not form a tight seal, which allows blood to leak backwards through
the valve when the heart muscle relaxes. Aortic valve regurgitation
may reduce blood flow to organs throughout the body, including the
heart muscle itself. As a result of the reduced blood flow, the
heart may need to pump harder, which over years, may enlarge the
lower left heart chamber.
During
the early stages of aortic valve regurgitation, a person may not
experience any symptoms, but the reduced blood flow eventually can
cause chest pain, palpitations or irregular heartbeats (arrhythmias),
a serious infection in the heart (endocarditis), heart failure,
and in rare cases, sudden death. Sometimes a person may only notice
symptoms once heart failure develops. There are certain instances
when aortic valve regurgitation can occur suddenly, and will include
severe symptoms such as shortness of breath and extreme tiredness.
In this case, a person should seek immediate medical attention.
Medications to lower blood pressure are usually used to treat aortic
valve regurgitation. If the valve leakage is severe and the heart
is unable to keep up with the increase in pumping, surgery may be
needed to replace the aortic valve.
Like aortic
valve regurgitation, mitral valve regurgitation usually develops
over many years. In the case of mitral valve regurgitation, a significant
amount of blood flows back into the left atrium through the leaky
mitral valve. In an attempt to circulate this extra blood, the left
ventricle pumps harder and may enlarge over time. After many years
of increase pumping, the left ventricle may become weaker and symptoms
of heart failure can develop.
Mitral
valve regurgitation is a common disorder, but the disorder can range
from mild to severe cases. Some people will never develop symptoms
and the condition may not get worse, but mitral valve regurgitation
can also develop suddenly. A person may experience symptoms such
as severe shortness of breath (dyspnea), fluid in the lungs and
chest pain. People who develop sudden mitral valve regurgitation
almost always need urgent surgery to repair or replace their mitral
valve.
A number
of causes can lead to both aortic valve regurgitation and mitral
regurgitation. Some causes include conditions such as aortic valve
stenosis and endocarditis;  infections
such as rheumatic fever and syphilis; injury, such as trauma to
the heart valve or aorta; inherited and autoimmune diseases; and
heart abnormalities present from birth. The use of diet drugs such
as fenfluramine and dexfenfluramine, appear to significantly increase
the risk of heart valve disease.
Depending
on the damage, heart valves may either be repaired or replaced.
Sometimes the surgeon can restore the valve to function normally
by remodeling the tissue (removing stretched tissue or sewing the
edges). Heart valves that are seriously deformed or degenerated
cannot be repaired. The old valve is removed and replaced with a
new valve mechanism. A new valve is attached by sewing it to a rim
of tissue kept from the original valve. The replacement heart valves
are either natural (biologic) or artificial (mechanical). Natural
valves are from human donors (cadavers), modified natural valves
are from animal donors (porcine: pigs), which are placed in synthetic
rings, and artificial valves are made of metal or plastic. Natural
valves rarely require life-long medication to prevent blood clot
formation (anticoagulation), whereas artificial valves will require
anticoagulation. 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 that causes the progressive narrowing of the blood
vessels of the lungs, which causes higher blood pressure in these
blood vessels and eventually leads to heart failure. Various studies
indicate that these diet drugs may increase the chances of developing
PPH by approximately 25 to 30 percent, especially in those people
who have used the drugs for more than three months.
The first
symptoms of PPH may be very minor, which sometimes delays the diagnosis.
A person with PPH may experience shortness of breath following exertion,
excessive fatigue, dizziness, fainting, ankle swelling, bluish lips
and skin and chest pain. Even if the disease has progressed, the
signs and symptoms may be hard to detect or even confused with other
conditions that affect the heart and the lungs. A physician may
determine if a patient has PPH through a cardiac catheterization.
PPH is
treated with a number of drugs, which can't cure or halt the progression
of this disease, but they may relieve symptoms. Some patients take
vasodilators,  which
help to dilate the blood vessels in the lungs, which reduces the
blood pressure in them. In addition, anticoagulants may be used
to decrease the tendency of the blood to clot in the lungs. Although
some patients do well with medication, others with severe PPH may
need a lung transplantation or heart and lung transplantation.
It is
hard to detect the number of PPH cases, however, it is estimated
that there are 300 new cases per year. PPH is more common in women
between the ages of 21 and 40, but it can affect anyone at any age.
About
6 million people took these diet drugs before they were pulled off
the market by the FDA in 1997. Recently, a $3.75 billion settlement
for thousands of people who took the Fen-Phen diet drug combination
received court approval and became final.
If you
took the diet drugs Pondimin® or Redux™, or if you took
the diet drug combination referred to as "Fen-Phen", you
may be entitled to receive cash benefits and also may be entitled
to medical testing services and other benefits under the court-approved
settlement agreement with American Home Products Corporation. To
receive these benefits, you must comply with certain filing requirements
and deadlines to preserve your rights under the settlement.
The law
firm of Whittemore, Denson PA represents persons who have taken
these diet drugs and will pursue and preserve your rights to compensation
and medical benefits. Please call for free consultation.
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