In 1997 the FDA approved
Meridia (sibutramine) a popular prescription medication
marketed by Abbott Laboratories. Meridia is an appetite
suppressant to be used along with a reduced-calorie diet
to help manage obesity. The drug works on two brain chemicals
that control appetite and make patients feel full. It
is recommended for people who are obese (about 30 pounds
or more over a healthy weight).
The FDA approved it for
prescription use after much debate about its side effects
and potential risks. One of the agency's medical officers,
Dr. Eric Colman, expressed great concern about sibutramine's
effects on blood pressure.
It is estimated that
over 8.6 million people in 70 countries have used Meridia.
It is an orally administered controlled substance, meaning
some patients could become addicted.
In March 2002, Public
Citizen, a US consumer watchdog group, asked the FDA
to recall Meridia based on reports of death and adverse
reactions noted from voluntary submissions by US physicians
and hospitals.
According to the petition
submitted by Public Citizen, as of September 2001 there
have been almost 400 serious adverse reactions reported
to the FDA since Meridia was first marketed in February
1998. These serious reactions have included 29 deaths,
over 150 patients hospitalized and approximately 150
patients diagnosed with a serious heart condition know
as arrhythmia.
The Italian Health Ministry
has suspended sales of the drug after reports of two
related deaths, two women ages 28 and 45. Italian officials
said they received 50 complaints about side-effects
from sibutramine (Reductil in Italy) (Chicago Tribune,
March 9, 2002).
In France, officials
reported 99 cases of side effects from sibutramine,
10 of them serious (Chicago Tribune, March 16, 2002).
Last year in Great Britain, the Drug and Therapeutics
Bulletin, published by the Consumers' Association, warned
the drug has limited benefits and unwanted side effects.
There have been reports of as many as 103 serious adverse
reactions in people using
the drug in France and the UK, including two deaths.
Side Effects of Meridia
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