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Is It Safe to Take Fen-Phen?
This article concerns the prescribing in combination of two anorexic (appetite
suppressing) drugs, Fenfluramine [fen] and Phentermine [phen], which separately
have been on the market since the 1970s. Physicians became interested
in combining the medications following the 1992 publication of a University
of Rochester study conducted by Dr. Michael Weintraub wherein he described
long-term successful weight loss results when combining the two medications.
Fen had always been known to have an appetite suppressing effect, but
had the undesirable side effect of making people sleepy. The gist of combining
the drugs was to counterbalance this sleepiness by adding phen, a mild
stimulant. The drugs are marketed under the catch phrase "fen-phen".
The drugs were prescribed to 18 million people last year. The Wall Street
Journal reports 18 million fen-phen prescriptions a month in 1996.
It is estimated
that 58 million Americans are clinically obese, those with a body weight
20-30% above normal. Obesity results from a complex interaction of genetic,
behavioral and environmental factors, is the second leading cause of preventable
death in the United States, and is a major cause of premature mortality.
Obesity is difficult to treat and brings along the associated health problems
of high blood pressure, diabetes, cardiovascular disease, and high cholesterol,
all of which can lead to heart attacks. Thus, it is no wonder that diet
medications which are safe and effective would be in high demand.
The idea of marketing
safe drugs to reduce excess weight is a relatively new phenomenon, since
diet pills in the past have been synonymous with amphetamines, conjuring
up, an image of sleazy feel-good doctors getting patients hooked on "speed".
Amphetamines, producing central nervous system stimulation, were originally
used in the treatment of narcolepsy and to combat mental depression, and
only later were tried for appetite control and in the treatment of obesity.
The use of amphetamines to control appetite in treating obesity has not
over the long term proved to be effective. Large doses of amphetamines
are toxic and prolonged use may cause drug dependence. Fen's pocket insert
advises that it is a controlled substance, related chemically to the amphetamines,
and drug dependence should be kept in mind when evaluating the desirability
of including the drug in weight reduction programs of individual patients.
Until recently, the national weight problem has been addressed by Americans
spending an estimated 33 billion dollars annually on diet books, joining
health clubs, and eating low calorie foods. Unfortunately for many, these
ideal remedies, based upon exercise and character-building restraint,
have not worked. And so a cross-section of Americans, from those who just
want to be cosmetically thin to those with a serious morbid obesity problem,
have longed for a drug or a combination of drugs which could be prescribed
by their physician and which would be both safe and effective in the long
Mechanism of Weight Loss
The non-obese person maintains normal weight without drugs. In a nutshell,
the normal person experiences a sense of fullness which provides physical
and emotional well being after eating. Simply stated, the body knows when
to say "I have had enough". Scientific study has established that these
feelings of satisfaction occur when certain neuro-transmitters in the
brain, molecules of serotonin, are released. Fen-phen stimulates the brain
to release an EXTRA amount of serotonin. Science reasons that if serotonin
brings satisfaction to the normal eater, then an extra amount of serotonin
will quicken the ending of the obese person's desire to eat. With appetite
reduced, over time, significant and lasting weight loss should occur,
or so goes the argument.
Associated with Fen-Phen
Concerns about the side-effects of fen-phen have increasingly become the
focus of media attention and a source of worry in the medical community.
On July 8, 1997 CNN reported information about an article to be published
August 27, 1997 in the New England Journal of Medicine revealing that
24 midwestern women have developed heart-valve disease as a direct result
of using fen-phen diet pills. Pre-publication release of information about
a medical article is unusual, reserved for only the most serious public
health matters, and highlights the urgency of the problem. Prior to this
announcement, fen-phen's most serious known side-effect was primary pulmonary
hypertension (PPH), a serious and potentially-fatal disorder in which
the arteries supplying the heart are constricted, producing abnormally
high blood pressure, shortness of breath and fatigue. European research
into fen-phen reveals that those using these drugs for more than three
months increase their risk of PPH from the normal 1 or 2 in 1 million
patients to 18 in l million. Other studies suggest the risk is 43 in 1
million. According to the Journal article, fen alters serotonin metabolism
in the brain while phen interferes with the pulmonary clearance of serotonin
in the blood stream, which may explain its association with PPH. Significantly,
the Journal article, states the association of valvular problems with
fen-phen is not likely due to chance and that candidates for the fen-phen
drug therapy should be informed about this serious potential adverse side
The FDA sent a letter on July 8, 1997 to thousands of doctors asking them
to immediately find out if their fen-phen patients have experienced symptomatology
suggestive of a heart valve problem. When untreated, valve problems can
lead to congestive heart failure. Valve damage causes blood to leak back
into the heart, making the heart work harder.
Redux is a single capsule prescription drug containing a refined version
of fen-phen and was popularized in September 1996 when Time magazine ran
a cover story on the hot new diet pill. Further notoriety came with publication
of a book - The Redux Revolution: ›Everything You Need to Know About the
Most Important Weight Loss Discovery of the Century. Sheldon Levine, its
author, proclaims "what makes Redux revolutionary is that it restores
confidence in one's own self-control".
While fen and phen are prescription drugs separately approved by the FDA,
only the Redux form of fen-phen has received FDA approval. Individually,
fen and phen were approved by the FDA for short term use only, while the
combination fen/ phen was approved for long term use in order to maintain
weight loss. Further, the FDA advised Redux was only to be prescribed
to those who have been diagnosed as obese (in adults a body mass index
greater than 27.8 kg/2m and in females greater than 27.8 kg/2m and in
conjunction with diet and exercise. However, critics like Lewis Seiden,
a pharmacologist at the University of Chicago, and others question the
FDA approval process, claiming that the FDA "glossed over evidence that
both Redux and the older drug fen cause significant brain damage in laboratory
animals". Originally, the FDA advisory committee rejected Redux on safety
grounds by a 5-3 vote. Later, Redux obtained FDA approval by a one-vote
The French Government has restricted the use of Redux to the morbidly
obese after it was discovered there were an estimated 20 deaths a year
associated with Redux. The state of Tennessee has altogether banned the
sale of fen-phen.
Physicians who prescribe fen-phen should realize the potential of liability
exposure. Physicians and the public should be aware that the combination
fen-phen (apart from Redux) is a drug which has not undergone FDA testing
(animal and clinical studies on humans) and therefore the utmost care
and consideration should go into the decision-making process of whether
to prescribe the drug. After prescribing the drug, physicians must supervise
the patient carefully to determine if there are any developing cardiopulmonary
side effects, to make sure the fen-phen drug therapy is working: weight
loss with safety.
In light of the information set forth in this article, a jury might conclude
that a defendant-physician, manufacturer, or weight loss clinic failed
to adequately warn a patient, failed to gain the informed consent of a
patient, misrepresented the safety of fen-phen, mistakenly prescribed
fen-phen in the first place, or failed to supervise the care of the patient
during drug therapy.
This informational piece was prepared by Monheit, Silverman & Fodera.
If you would like more information on this topic, call us at (800) 220-LAW1, or use the
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