HHS NEWS

P97-32                        FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE         Lawrence Bachorik:  (301) 827-6250
September 15, 1997            
                              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.  

Other Fen-Phen Links
Questions and Answers (9/15/97)	Previous CDER Fen-Phen Information		Mayo Clinic