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What is Fen-Phen?

Fen-phen was an anti-obesity medication (an anorectic) which
consisted of two drugs: fenfluramine and phentermine.

After reports of heart valve disease and pulmonary
hypertension primarily in women who had been undergoing
treatment with Fen-phen, the FDA requested its withdrawal from
the market in September 1997.

The action was based on findings from doctors who had
evaluated patients taking these two drugs with
echo cardiograms, a special procedure that can test the
functioning of heart valves. These findings indicated that
approximately 30 percent of patients who were evaluated had
abnormal echo cardiograms, even though they had no
symptoms. This is a much higher than expected percentage of
abnormal test results.

In July 1997, researchers at the Mayo Clinic and Mayo
Foundation reported 24 cases of rare valvular disease in
women who took the "Fen-phen" combination therapy. FDA
alerted medical doctors that it had received nine additional
reports of the same type, and requested all health care
professionals to report any such cases to the agency’s
med watchHg program or to the respective pharmaceutical
manufacturers.

Subsequently, FDA received 66 additional reports of heart
valve disease associated mainly with "Fen-phen." There were
also reports of cases seen in patients taking only fenfluramine
or dexfenfluramine. FDA requested that the manufacturers of
fenfluramine and dexfenfluramine stress the potential risk to
the heart in the drugs’ labeling and patient package inserts. As
of 1997, the FDA continued to receive reports of cardiac
valvular disease in persons who have taken these drugs.

As of 2004, Fen-phen is no longer widely available. In April 2005,
American Lawyer magazine ran a cover story on the Fen-phen
mass tort crisis and reported that more than 50,000 product
liability lawsuits had been filed by alleged Fen-phen victims.
Estimates of total liability run as high as $14 billion.
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