Femara linked to Birth Defects

Femara (letrozole) has been approved by the FDA to treat breast cancer in post-menopausal women. But, many doctors also prescribe the drug as an infertility treatment, a non-approved use, despite the known risks of birth defects and miscarriages.

Novartis, the maker of Femara, recently issued a letter to doctors in the U.S. and Canada warning them against non-approved uses of the drug. To date, Novartis has received 13 adverse reports of women prescribed Femara during pregnancy - approximately 30% of these reports indicated harm to the baby, such as birth defects.

Animal studies have shown that Femara can cause harm to the fetus when prescribed to the pregnant female. Specifically, in small doses, the drug was show to be embryotoxic, fetotoxic, and teratogenic - causing harm and birth defects to the unborn baby.

Doctors and fertility clinics are currently using Femara to induce ovulation in infertile females. The Femara website states very clearly, "You should not take FEMARA if you are pregnant as it may cause fetal harm. You must be postmenopausal to take FEMARA." In the prescribing information, Novartis warns, "If there is exposure to letrozole [Femara] during pregnancy, the patient should be apprised of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Femara In the News

Femara continues to be used by fertility specialists to induce ovulation by suppressing the production of estrogen. To inform doctors of the risks of birth defects, Health Canada urged drug maker, Novartis to send out a warning letter. (Nov-29-05) [SAN JOSE MERCURY NEWS]

Novartis outlines specific safety information on Femara for doctors and patients. [FEMARA]

Register your Femara Complaint

If you or a loved one has suffered from a miscarriage or newborn's death or birth defect and the mother was prescribed Femara before pregnancy, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please fill in our form on the right to submit your complaint and we will have a lawyer review your Femara complaint.

At, it is our goal to keep you informed about important legal cases and settlements. We are dedicated to helping you resolve your legal complaints.

Reader Comments

Posted by

Took Femara X 5 cycles 7/08-11/08. I believe it was the 2.5 dose. Became pregnant on my own 1/09. Baby was diagnosed with holoprosencephaly and Trisomy 13 @ 20 week level II anatomy scan. She also has a congenital heart problem and a gastrointestinal hernia. I am not willing to terminate, so we don't know if the baby girl will be miscarriage or stillbirth YET. Geneticist says she will die before or shortly after birth.

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