FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.




EMBARGOED FOR RELEASE WEDNESDAY, AUGUST 27 AT
5:00 P.M.


T97-39                      Susan Cruzan:     301-827-6242
August 27, 1997              
                            Consumer Hotline: 800-532-4440 


HEALTH ADVISORY ON FENFLURAMINE/PHENTERMINE FOR OBESITY  

     FDA is taking measures to strengthen its recent warning that
treatment of patients for obesity with a combination of
fenfluramine and phentermine has been associated with the
development of a serious heart valve disease. Based on additional
reports of abnormalities in mitral, aortic, and tricuspid heart
valves of patients on such regimen, the agency has requested the
manufacturers of phentermine, fenfluramine, and the chemically 
related dexfenfluramine to stress this potential risk in the
drugs' labeling and patient package inserts.
     The following can be used to answer questions:
     Phentermine and fenfluramine, which are approved as appetite
suppressants for single use in short-term obesity therapy, have
recently been widely prescribed "off-label" in combination and
for long-term management of obesity. In July, researchers at the
Mayo Clinic and Mayo Foundation reported 24 cases of a rare
valvular disease in women who took the combination therapy, and 
FDA notified medical practitioners and institutions that it had
received nine additional reports of valvulopathy associated with
the off-label use.
     The agency also asked -- and continues to request -- all
health care professionals to report any such cases and other
toxicities associated with the use of the three drugs to its
MedWatch program (1-800-FDA-1088/fax 1-800-FDA-0178) or to the
respective pharmaceutical manufacturers.
     Thanks to these reports, as of August 22, FDA has
information about 58 additional cases of cardiac valvular disease
in patients -- two of whom were men --  on fenfluramine and
phentermine. Severity was graded as moderate or severe in over
three-fourths of the cases, and two of the reports described
deterioration from no detectable heart murmur to need for a valve
replacement within one-and-a-half years. At least one of these
patients died folowing a surgery to repair the valves. (The
agency's findings, as of early in August, are described in more
detail in the current issue of The New England Journal of
Medicine, which also carries the Mayo study.)
     Since the cause-effect relationship between the use of these
drugs and the development of the valvular disease has not been
conclusively established, FDA is working with the Centers for
Disease Control and Prevention, the National Institutes of Health 
and with the Mayo researchers to develop methods to investigate
the scope and cause(s) of the problem. In the meantime, the
agency wants to make sure that the potential risk of the 
combination therapy is known to both the prescribers and their
patients.
     The agency therefore has requested the manufacturers to 
revise the drugs' labels to emphasize the new information in a
prominently displayed boxed warning, and to develop patient
package inserts to alert potential users to the same facts and
concerns.  Additional steps to ensure that patients are able to
make informed decisions about the use of these drugs are under
consideration.
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