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Medical News and Perspectives
February 5, 2003

FDA Orders Estrogen Safety Warnings

JAMA. 2003;289(5):537-538. doi:10.1001/jama.289.5.537

The US Food and Drug Administration (FDA) is requiring new safety changes to the labels of all products containing estrogen alone or combined with progestin for use by postmenopausal women, warning that the drugs may slightly increase the risk of heart attack, stroke, breast cancer, and blood clots.

An estimated 10 million postmenopausal women in the United States currently use estrogen-based hormone replacement therapy (HRT) to ease menopausal symptoms and prevent osteoporosis, the agency said.

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