Advisory

Correction

2002-79
November 26, 2002
For immediate release

Tamoxifen associated with increased risk of stroke, pulmonary embolism, and uterine cancer

OTTAWA - Health Canada is advising Canadians about potential side effects of the drug Tamoxifen that include an increased risk of stroke, pulmonary embolism (blood clots in the lung), and cancer of the uterus (womb).

This safety information has been provided to health care professionals to review with patients prior to prescribing Tamoxifen. Tamoxifen is a medication used in Canada for the treatment of breast cancer and is taken in tablet form.

New information from a recent long-term clinical study called the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention shows an increased risk of stroke, blood clots and cancer of the uterus in high-risk patients using Tamoxifen for the prevention of breast cancer. For these patients, the potential risks associated with Tamoxifen may be greater than the potential benefits. Physicians and their patients must discuss risks and benefits prior to prescribing Tamoxifen. The use of Tamoxifen for the prevention of breast cancer is not an approved indication in Canada.

It should be noted that the benefits of using Tamoxifen in the treatment of breast cancer outweighs the risks of side effects for the majority of patients.

Patients who are taking Tamoxifen should immediately report to their doctor any of the following symptoms: weakness or numbness of the face, arms or legs, and problems with speech or vision which may indicate stroke; leg swelling, chest pain or shortness of breath which may indicate blood clots; and abdominal pain or abnormal vaginal bleeding which may indicate cancer of the uterus. Patients should inform their doctor if they have had a history of stroke or stroke-like events, blood clots or uterine cancer.

-30-

Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991