Warning that breast cancer drug can harm fetus

August 29, 2015

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 Staff

In the research by Neyt and his colleagues an economic evaluation of the drug was carried out.

It was found that prices for the drug varied from 928 Euros ($1,096) per 150 mg vial in Norway to 647 Euros in Belgium and 595 Euros in England.

According to the researchers there are in Belgium more than 6,600 cases of breast cancer a year.

Of these about 45 percent would be in the earlier stages of disease in which the drug would be used and about a quarter of them would have the type of disease that responds to Herceptin.

Providing the drug to all these patients would cost about 34,000 Euros per patient or a total of 25.5 million Euros.

Neyt and his team advise that countries should not rush to prescribe the drug before they calculate the implications of re-allocating resources and should bargain over the price of the drug.

Neyt says the aim should be to arrive at a price that results in cost-effective treatments, which budgets can bear, even if the drug is provided for a large number of women.

The research is published in the Annals of Oncology.

News-Medical Staff