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Breast Cancer Blog: Novartis Issues Warning Regarding Femara

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Nov 29, 2005

Novartis Issues Warning Regarding Femara

Novartis Issues Warning Regarding Femara
Birth defect associated with thalidomide
The makers of the breast drug Femara (Letrozole) is issuing warning that this drug may cause birth defects. This warning comes in light of reports that suggest Femara is being used to help a woman become pregnant.

After reading this news, I was thinking of the thalidomide tragedy. It was on one those black days of 1953 thalidomide was introduced into the market. Thalidomide was prescribed to treat morning sickness in pregnant women. Thousands of women took the drug and the lives of thousands of yet unborn children changed forever. Thalidomide tragedy stands alone as the worst tragedy in the pharmaceutical world. We sure do not want another thalidomide like tragedy.

Femara has only one FDA approved indication, treatment of breast cancer in post-menopausal women, that's it. Fertility doctors claim that due to drug's suppression of estrogen it can promote ovulation. The U.S. label on the drug already warns that it has been associated with birth defects, but concerns arose when a researcher in Canada published a report noting cases where the drug had been given to pregnant women.

Novartis is sending letters to fertility doctors worldwide to reiterate a warning that the drug should not be given to women who may be pregnant.

Health Canada, the country's health care agency, issued the warning jointly with Novartis to fertility specialists, gynecologists and obstetricians. In its letter in Canada, 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," the company said.


Emily      Return to Breast Cancer Blog Main


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Breast cancer
Every year, more than 200,000 women are diagnosed with breast cancer in the United States. Breast cancer ranks second as the leading cause of cancer deaths in American women. Until recently breast cancer topped the list of leading causes of cancer deaths in women, but lately lung cancer has claimed the top position. If skin cancer is excluded, breast cancer is the commonest cancer among American women.

Breast Cancer Blog: Novartis Issues Warning Regarding Femara

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