FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen)
P97-32
FOR IMMEDIATE RELEASE
September 15, 1997 |
FOOD AND DRUG ADMINISTRATION
Lawrence Bachorik: (301) 827-6250
Broadcast Media: (301) 827-3434
Consumer Hotline: (800) 532-4440 |
FDA ANNOUNCES WITHDRAWAL OF FENFLURAMINE AND DEXFENFLURAMINE
The Food and Drug Administration, acting on new evidence about significant side-effects
associated with fenfluramine and dexfenfluramine, has asked the manufacturers to
voluntarily withdraw both treatments for obesity from the market. Dexfenfluramine is
manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by
Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J.,
which also manufactures and markets fenfluramine under the brand name Pondimin. Both
companies have agreed to voluntarily withdraw their drugs. The FDA is not requesting the
withdrawal of phentermine, the third widely used medication for obesity.
The action is based on new findings from doctors who have evaluated patients taking
these two drugs with echocardiograms, a special procedure that can test the functioning of
heart valves. These findings indicate 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.
“These findings call for prompt action,” said Michael A. Friedman, M.D., the
Lead Deputy Commissioner of the FDA. “The data we have obtained indicate that
fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable
risk at this time to patients who take them.”
FDA recommends that patients using either of these products stop taking them. Users of
these two products should contact their doctors to discuss their treatment.
These new findings suggest fenfluramine and dexfenfluramine are the likely cause of
heart valve problems of the type that prompted FDA’s two earlier warnings concerning
“fen-phen,” a combination of fenfluramine and phentermine. “Fen-phen”
has been widely used off-label in recent years for the long-term management of obesity.
In July, 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 (1-800-FDA-1088/fax 1-800-FDA- 0178) 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. FDA continues to receive reports of cardiac valvular disease in
persons who have taken these drugs.
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