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Fen Phen Lawsuit Information
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 echocardiograms, 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 echocardiograms, 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 MedWatch 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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