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Swiss drug manufacturer Novartis is warning fertility doctors that its breast cancer drug, marketed under the name Femara (letrozole), has been associated with birth defects. The safety warning was prompted by reports that Femara was being used to help a woman become pregnant.

Femara is only approved for use in postmenopausal women with breast cancer, but evidence indicates some doctors have prescribed it as a fertility treatment because it suppresses estrogen and can promote ovulation. Novartis is sending letters to fertility doctors worldwide in response to these reports to reiterate a warning that the drug should not be given to women who may be pregnant.

In the U.S., Femara labels already warn that the drug has been associated with birth defects, but after a researcher in Canada published a report noting cases where the drug had been given to pregnant women, safety concerns increased. Novartis responded to the report by reviewing its safety database, finding despite its warning label there were 13 reports of pregnant women receiving the drug worldwide.

Of the 13 women, at least two had miscarriages and two had children with birth defects, according to a company spokeswoman. It was not clear how many of the women were given Femara to increase their fertility.

Canada''s health care agency, Health Canada, issued a joint warning with Novartis that it is “aware that Femara 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.” Pregnant women who have received the drug should contact their physicians because of the potential harm to the mother and the fetus, including risk of fetal malformations.

Though the U.S. Food and Drug Administration has not taken any action, a spokeswoman for the agency said the safety concerns were being reviewed. Novartis said it plans on sending a letter to U.S. fertility specialists by the end of the week.

It is currently unknown how many women might be affected by the renewed Femara safety warnings.