NEWS
04/08/1994

<TITLE>Stronger warning to women and doctors that tamoxifen poses an increased risk of cancer of the uterus</TITLE>
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P94-8                           Food and Drug Administration
FOR IMMEDIATE RELEASE           Press Office (301) 443-3285
April 8, 1994                   National Cancer Institute
                                Press Office (301) 496-6641 


     The Food and Drug Administration announced today a stronger
warning to women and doctors that tamoxifen, an anti-cancer drug
used in treatment of breast cancer, poses an increased risk of
cancer of the uterus.
     Despite the increased risks, however, the latest study
results have reaffirmed that tamoxifen can delay or prevent
relapse in patients who have undergone surgery for breast cancer. 
Therefore, tamoxifen continues to be indicated for the treatment
of breast cancer.
     The updated warning is based on the drug's package insert
that has been revised to reflect the most recent data from large
randomized trials.  The manufacturer of tamoxifen, Zeneca
Pharmaceuticals, is sending the updated labeling information in a
"Dear Doctor" letter to 380,000 oncologists and health care
professionals.
     "Tamoxifen is a valuable treatment for breast cancer, but it
is important for women to recognize that there are side effects
including an increased risk of cancer of the uterus," said FDA
Commissioner David A. Kessler, M.D.  "Women must also be advised 
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                                   Page 2, P94-8, Tamoxifen
that if they have used the drug, they need to get regular
gynecologic exams and report to their doctor any abnormal vaginal
bleeding or discharge."
     A study in Sweden, which has now followed participants for
about nine years, showed that breast cancer patients who take
tamoxifen have a higher risk of uterine cancer than had been
suggested on the basis of earlier research.  In the latest
results of this study, 23 of the 1,372 patients randomized to
take tamoxifen developed the disease, compared with 4 of the
1,357 patients in the control group.  The ongoing B-14 trial of
the National Surgical Adjuvant Breast and Bowel Project produced
similar results after 6.8 years of follow-up.
     These data taken together show that women taking tamoxifen
face a risk of uterine cancer about two to three times higher
than the risk for women without breast cancer in the general
population.   Additional studies are under way to more clearly
define the role of other risk factors, such as prior hormone use.
     Recent unpublished data suggest a possible increase in
cancers in the gastrointestinal tract among women receiving
tamoxifen.  These results are at odds with other trials, and the
potential risk is being evaluated.  In addition, animal studies
continue to support long-held concerns that use of tamoxifen in 
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                                      Page 3, P94-8, Tamoxifen 
pregnancy might cause fetal harm, and raised the possibility of
causing DES-like syndrome.
     The FDA-revised package insert and the manufacturer's letter
to the health care professionals provide information on the new
findings and suggest steps that should be taken by women who are
using or have used tamoxifen.  FDA has also taken steps to ensure
that the new findings are reflected in the informed consent
document for women participating in NCI-sponsored studies using
tamoxifen, and that all women taking tamoxifen for treatment are
informed about updated risk information.    
     The NCI emphasizes that the benefits of tamoxifen as a
treatment for breast cancer far outweigh the potential risks of
other cancers.  NCI's current clinical trial to study tamoxifen
as a preventive agent is based on evidence that the drug reduces
the risk of a new cancer in the other breast.  Data also suggest
that tamoxifen may decrease cardiovascular disease and stabilize
postmenopausal bone loss.
     NCI emphasizes, however, that tamoxifen should not be used
as a preventive agent outside of a clinical trial.     
     Tamoxifen is marketed under the trade name Nolvadex by
Zeneca Pharmaceuticals, Wilmington, Del.
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