Novartis’ Femara in birth defect warning

Novartis has issued a worldwide warning following reports that its breast cancer drug, Femara (letrozole) is being wrongly used as an aid to fertility.

The drug has been associated with birth defects and is only approved for the treatment of breast cancer in postmenopausal women.

However, the drug suppresses estrogen and can promote ovulation and a researcher in Canada published a report noting cases where the drug had been given to pregnant women.

This has prompted Novartis to send letters to fertility doctors worldwide to reiterate a warning that the drug should not be given to women who may be pregnant

Novartis’ own research found 13 cases around the world where Femara had been given to pregnant women. Of those 13, two had miscarriages and two children were born with birth defects.

In its letter to Canadian doctors, Novartis said 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.”

The drug “should not be used in women who may become pregnant, during pregnancy and/or while breast-feeding, because there is a potential risk of harm to the mother and the fetus, including risk of fetal malformations.”

© Adfero Ltd