Warning that breast cancer drug can harm fetus

Nov 30 2005

Health Canada along with drug company Novartis Pharmaceuticals Canada, have issued a warning concerning the drug Femara (letrozole), which is used to treat breast cancer in women who are postmenopausal.

They are saying that the drug should not be used in women who may become pregnant.

It appears that the Novartis drug is being used to stimulate ovulation in women who are infertile, or unable to become pregnant, as a treatment to increase their chances of becoming pregnant.

Novartis says that physicians treating their patients for infertility need to be reminded that Femara is authorized for use in post-menopausal women with breast cancer only.

The company say there is no authorisation for the use of Femara for the purpose of inducing ovulation and increasing the chance of pregnancy, and it should not be used in women who may become pregnant, during pregnancy and/or while breastfeeding, because there is a potential risk of harm to the mother and the fetus, including risk of fetal malformations.

The company are saying that if there is exposure to Femara during pregnancy, the patient should contact her physician immediately to discuss the potential of harm to the fetus and potential risk for loss of the pregnancy.

Novartis has issued a letter to Canadian obstetricians, gynaecologists and fertility specialists advising them of this safety information.

Novartis says it is committed to the delivery of quality pharmaceutical products and to ensuring the timely communication of safety information that is important to patients and health care professionals.

They advise any questions about current prescriptions be directed to a physician or a pharmacist.

News-Medical.Net Staff