Among
prescription
appetite suppressants, most people remember the Fen-Phen debacle.
The combination of phentermine and fenfluramine or dexfenfluramine were
prescribed for thousands of people with weight problems in the mid-1990s.
Fen-Phen was
hailed as the new magic bullet, and there was tremendous excitement about it, as
early trials showed promising results. People also had a sense of confidence
about its safety and efficacy, because it had been through the rigors of FDA
testing.
Phentermine is an andrenergic, which means it is activated by the body’s natural epinephrine
(adrenaline) supply or another epinephrine-like substance. Like an amphetamine,
it acts to stimulate metabolism and suppress the appetite.
Fenfluramine
and dexfenfluramine also increased serotonin levels in the brain and enhanced
the appetite suppression effects of phentermine while alleviating some of its
unpleasant stimulant effects.
Fen-Phen was
indeed effective in helping people lose weight, but it also turned out to be
associated with numerous cases of valvular heart damage. Some people died,
others were hospitalized. Even though the combination drug was subjected to
extensive testing, this was a side effect that researchers hadn’t discovered
before it was released to the public and subject to broader use.
In 1997,
fenfluramine and dexfenfluramine were withdrawn from the U.S. market, to much
objection and outcry from patients—presumably those without heart damage—who
were successfully losing weight with the help of Fen-Phen. Only phentermine
remains available.
The Fen-Phen
situation remains an oft-cited example of the very real danger of drug
interactions. Even with the rigorous testing the drug was subjected to in
controlled studies, the problem with heart trouble wasn’t detected until it was
released and began to be used by thousands of patients. Only then did the
frequency of heart problems become clear.
Another
weight-loss medication that was pulled is Phenylpropanolamine. Once sold under
prescription as Destrim, and over the counter in various weight-loss products
and cold treatments, it was removed from the market in 2000 after a large study
found that it increased the risk of hemorraghic stroke.
Sibutramine
(Meridia) was approved for weight-loss treatment in 1998, just in time to fill
the void left by Fen-Phen. Not surprisingly, an eager public seized upon it as
the new hope.
Like
fenfluramine and dexfenfluramine, sibutramine affects the function of serotonin
in the brain, though sibutramine goes about it differently, and it doesn’t
produce the adverse side effects on the heart. Sibutramine at 10 to 30 mg per
day has helped patients reduce their weight by up to 10 percent over six to 12
months, which is above average. In three studies, up to 25 percent of lost
weight was regained within one to six weeks of stopping medication, and in
another study, up to 80 percent of weight lost was regained within three months
of stopping medication.
But patients
who stay on sibutramine typically gain back less than 20 percent of the weight
lost.
And there’s
the rub! Unlike most weight-loss medications, sibutramine actually is approved
by the FDA for long-term use of more than 12 months, so patients may be able to
get a supportive regimen of medication for a longer period with
sibutramine.
But once
again, there’s no perfect safe solution. Other safety concerns about sibutramine
led to its removal from the market in Italy, and France and Great Britain are
considering similar action because of reports of heart attack, stroke,
arrhythmia, and some deaths in patients taking sibutramine, even though a clear
causal relationship hasn’t been established.
Doctors and
researchers know that sibutramine does increase blood pressure and heart rate,
but no one knows yet if it’s responsible for causing heart attack or some other
serious adverse effects. Until this is better understood, if your doctor
suggests using sibutramine, remember that diligent tracking of your blood
pressure will be essential.
And if you
already have coronary artery disease, heart failure or high blood pressure,
remember that the purpose of losing weight is to improve your health. The amount
of loss you could get from sibutramine would not justify recklessly elevating
your current risks, so you probably should not be on sibutramine at all.
THROUGH THICK & THIN: Appetite Suppressants
Appetite suppressants don’t alleviate the need to
change unhealthy dietary habits. You still have to learn how to
eat properly and take care of your nutritional needs. It does no
good to eat less overall, but then to ingest junky calories when
you do eat.
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Caroline J. Cederquist, M.D. is a board certified Family Physician and a board certified Bariatric Physicians (the medical specialty of weight management). Dr. Cederquist is the founder of Bistro M.D., a home diet delivery program that specializes in low calorie gourmet food that is delivered to your home or office. Bistro M.D. serves as culmination of Dr. Cederquist's expertise and experience in the world of medical weight loss.