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Canadians warned on drug misuse
WASHINGTON - A drug used to increase a woman's chances of becoming pregnant may cause birth defects and miscarriages, according to a safety alert issued Monday by Canadian health regulators.
Letrozole, sold under the brand name Femara, is approved to treat breast cancer in women who have undergone menopause. But doctors in the United States and Canada often prescribe it "off label" to prompt ovulation as part of fertility treatments.
Health Canada, the government's national health-care agency, and Novartis, a Swiss drug maker, have sent letters to Canadian doctors warning them about the off-label, or unapproved, use of the drug. Health Canada posted copies of the letter and a patient safety alert on its Web site Monday.
Although the U.S. Food and Drug Administration isn't requiring it, Novartis will send a similar letter to U.S. fertility specialists to remind them that Femara is approved only as a breast-cancer treatment, said Kim Fox, a Novartis spokeswoman.
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