ZURICH (Reuters) – Novartis has warned doctors not to use
its hormone-based breast cancer drug Femara to help women
become pregnant after reports of adverse events following such
off-label use.
Novartis had found 13 reports of cases where individual
doctors had prescribed Femara for ovulation induction in its
safety data base, a spokeswoman said.
This lead to birth defects in two cases and two spontaneous
miscarriages in two others. There were four normal births,
while there was a lack of information in the five remaining
cases.
“Novartis simply encouraged physicians and patients to
stick to the prescribed information,” the spokeswoman said.
“This indication is not approved and Novartis never did
anything to promote it.”
Femara is for use in post-menopausal women only, she said,
but some doctors across the world had prescribed the drug to
treat infertility in women, leading to the reports.
Novartis shares were 0.8 percent lower at 68.80 Swiss
francs by 1500 GMT, having hit a low of 68.10 francs earlier.
Novartis is seeking wider indications for Femara. U.S.
regulators in August agreed to speed up their review process on
whether to allow it to be used by women with breast cancer
immediately following surgery to remove a tumour.
Femara is the second in a new class of hormone-based
breast-cancer treatments called aromatase inhibitors to have
demonstrated an advantage over tamoxifen, currently standard
treatment for women with breast cancer.
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