MEDICAL INFORMATION
This class action lawsuit alleges,
among other things, that taking Ponderal®, Redux™ or “Fen-Phen” may produce
lesions or abnormalities in the heart valves of some people (“Valvular Heart
Disease”). It also alleges that
Ponderal®, Redux™ or “Fen-Phen may cause Primary Pulmonary Hypertension
(PPH). Servier Canada Inc./Biofarma
S.A. has defended vigorously against this lawsuit and disputes the claims made.
IMPORTANT HEALTH CANADA WARNING
Health
Canada urges all individuals who may have consumed these products (Ponderal®,
generic name fenfluramine or Redux™, generic name dexfenfluramine) to consult
their doctor immediately for appropriate patient follow-up.
VALVULAR HEART DISEASE
In the spring
of 1997, doctors at the Mayo Clinic reported that some of their patients who
used Ponderal® and/or Redux™ had developed lesions of their heart valves. This class action lawsuit contends that
subsequent research has indicated that the use of Ponderal® and/or Redux™ may
cause an increased risk of heart valve lesions or abnormalities in some people
who took these drugs and that this risk is related to the length of time over
which the diet drugs were taken. In
general, people who used the diet drugs for very short periods of time have a
lower risk than those who took them for
longer periods.
The heart valve abnormalities which have appeared in some
diet drug users occur in
the two valves which are located in the left side of the
heart. One of these valves is the “aortic
valve” which is the gateway to the outflow of blood from the heart. The
other left-sided heart valve is the “mitral
valve” which is the gateway from the upper chamber of the heart (which
collects blood from the lungs) to the lower chamber of the heart (which pumps
blood to the body).
The heart valves are like tiny gates in the heart that help
blood to move forward in the heart through the lungs, and out into the body.
The heart valve lesions that have developed in diet drug users allow blood to
flow backwards in the wrong direction. This condition is called
“regurgitation.”
There are four levels of regurgitation—
• trace or physiologic,
• mild,
• moderate, and
• severe.
Trace or physiologic regurgitation of either the aortic or mitral valve
and mild regurgitation of the mitral valve
is very common, even among people who never used diet drugs and is not
generally considered abnormal.
Mild, moderate or severe regurgitation of the aortic valve and moderate or severe regurgitation of the mitral valve are abnormal and, in some
cases, may be medically significant.
The abnormalities that cause mild, moderate or severe regurgitation of
the aortic valve and moderate or
severe regurgitation of the mitral valve
can be described as Valvular Heart Disease or “VHD”.
Many doctors believe that individuals who have VHD may be at risk for
developing an infection in their hearts if bacteria enter the bloodstream
during routine dental hygiene or surgery.
Therefore, current medical practice is to recommend that individuals
with VHD receive antibiotics when they have their teeth cleaned or undergo some
kinds of surgery.
“Severe” valvular regurgitation is a serious condition that can damage
the heart if it is not promptly and properly treated. Appropriate treatments
may include the use of medications and repair or replacement of the diseased
valve through open-heart surgery.
Presently, there is little specific scientific evidence on whether the
type of VHD that has been linked to diet drug use is progressive in nature.
However, many respected doctors and researchers have concluded that certain
other types of VHD (unrelated to diet drug use) are progressive in nature—that
is, that mild to moderate regurgitation can progress to more severe levels of
regurgitation over time. Individuals
with VHD should see their doctors at least once a year for evaluation.
Valvular heart disease may be without symptoms. Doctors can often determine if regurgitation is present by
listening for a heart “murmur” with a stethoscope, but some studies show that
they sometimes miss hearing the “murmurs.” There is a way, however, that
doctors can determine more accurately whether or not someone has valvular
regurgitation or whether diagnosed regurgitation is progressing to more severe
levels of valvular heart disease—that is by performing an echocardiogram.
An echocardiogram is a simple, safe, quick and painless outpatient test
in which high frequency sound waves are used to create a moving picture image
of the heart and its valves. The technology is the same as the ultrasound technology
that is used to see the image of a developing fetus in a pregnant woman. From
start to finish, the echocardiogram usually takes less than an hour and is done
either in a qualified doctor’s office or an out-patient clinic of a hospital.
You do not need to fast or take medication or prepare in any way prior to the
procedure, and the procedure is done while you are completely awake. A
videotape or computer disk is made of the pictures of the heart, which is
reviewed by a qualified doctor and can be saved for later comparison.
PRIMARY PULMONARY HYPERTENSION (PPH)
Pulmonary Hypertension (PH) is a rare
and serious lung disorder in which the pressure in the pulmonary artery (the
blood vessel that leads from the heart to the lungs) rises above normal levels
and may become life threatening. Symptoms of PH include shortness of breath
with minimal exertion, fatigue, dizzy spells and fainting. PH is extremely
rare, occurring in about 2 persons per million.
Diet drug-induced pulmonary
hypertension exists where medical evidence indicates that the diet drugs were
substantial factors causing individuals to suffer from debilitating,
potentially fatal instances of elevated pulmonary and right-sided heart
pressures, a condition often otherwise referred to as Primary Pulmonary Hypertension (PPH). Existence of diet
drug-induced pulmonary hypertension is normally established through thorough
investigation of other potential causes for elevated pulmonary and right-sided
heart pressures. Other potential causes for these elevated pressures may
include severe sleep apnea, emphysema, pulmonary emboli, certain congenital
heart defects, left heart failure, autoimmune disorders, and others. As with VHD, testing is done by
performing an echocardiogram.
Symptoms
The first symptom is frequently tiredness, with many patients thinking
they tire easily because they are simply out of shape. Difficulty in breathing
(dyspnea), dizziness, and even fainting spells (syncope) are also typical early
symptoms. Swelling in the ankles or legs (edema), bluish lips and skin
(cyanosis), and chest pain (angina) are among other symptoms of the disease.
Patients with PPH may also complain of a racing pulse; many feel they have
trouble getting enough air. Palpitations, a strong throbbing sensation brought
on by the increased rate of the heartbeat, can also cause discomfort.
Some people with PPH do not seek medical advice until they can no longer go
about their daily routine. The more severe the symptoms, the more advanced the
disease. In these more advanced stages, the patient is able to perform only
minimal activity and has symptoms even when resting. The disease may worsen to
the point where the patient is completely bedridden.
For More Information
Contact:
The Pulmonary Hypertension Society Of Ontario
2510 Ouellette Avenue
Windsor, Ontario
N8X 1L4
Email: info@phs.on.ca
Web Site: www.phs.on.ca