Is Phentermine Legal?
U.S. Department of Health and Human Services
| FOR IMMEDIATE RELEASE | July 8, 1997
FOOD AND DRUG ADMINISTRATION
Bradford Stone: (301) 443-3285
Consumer Hotline: (800) 532-4440
HEALTH ADVISORY ON
FENFLURAMINE/PHENTERMINE FOR OBESITY
FDA today alerted physicians to reports of valvular heart
disease in women treated for obesity with a combination of fenfluramine and
phentermine. The drugs were approved individually more than 20 years ago for
single-drug, short-term obesity therapy. Recently, however, they have been
widely used "off-label" in combination and for long-term management
of obesity. FDA is unaware of studies adequately demonstrating the safety and
effectiveness of these products when used in combination.
"These are drugs that should be taken only by obese patients in
conjunction with a weight loss regimen that includes a reduced-calorie diet and
an exercise program, in accordance with approved labeling" said lead
deputy FDA Commissioner Michael Friedman.
In a letter to doctors, FDA noted that as of July 8, 1997, the agency has
received reports of 33 cases of unusual abnormalities in mitral, aortic, and
tricuspid heart valves in women between the ages of 30 and 72 who had been
taking fenfluramine and phentermine for 1 month to 28 months. The course of the
disease when the drugs are stopped is unknown at this time.
Researchers at the Mayo Clinic and Mayo Foundation, Rochester, Minn., today
also announced results of a study of valvular disease in women who took the
combination of fenfluramine and phentermine for management of obesity, to be
published in the New England Journal of Medicine next month.
There is no conclusive evidence of a cause-effect relationship between use
of the drugs and the development of valvular disease. However, because of the
seriousness of the cardiac problems and their rare occurrence in otherwise
healthy obese women in this age range, FDA believes patients and health care
professionals should be notified of this information. In addition, the agency
is notifying manufacturers to meet with FDA to discuss possible labeling
FDA will continue to monitor adverse events reports from all sources. The
agency encourages all health care professionals to report any cases of cardiac
valvular disease or other serious toxicities associated with the use of
fenfluramine, dexfenfluramine, or phentermine to the FDA's MEDWATCH program at
1-800-FDA-1088/fax 1-800-FDA-0178; or to the respective drug manufacturers. Of
particular interest would be information from such patients on the dosage and
duration of therapy with the drug product(s), whether there were any other
medications being taken by the patient on a chronic basis, whether there was
any history of pre-existent cardiac disease, the results of the patient's cardiac
evaluation, and the degree of obesity at the time drug therapy was started.
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, 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.
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