FDA Mandates Warnings for Hormone Replacement Drugs

by Erik Swain, Managing Editor

FDA has mandated new warnings on labels of products for hormone replacement therapies containing estrogen or progestin.

The changes came after FDA analyzed data from a landmark study sponsored by the National Institutes of Health (NIH; Bethesda, MD) that raised concerns about risks of using those products, especially those regarding cardiovascular diseases and breast cancer.

The most significant changes are a new boxed warning reflecting new risk information as determined by the NIH study and changes to the approved indications to encourage patients to consult their doctors about whether they should continue to use the products. The boxed warning notes the increased risk of heart attacks, heart disease, strokes, and breast cancer, and explains that the products are not approved for heart disease prevention.

The agency approved new labeling for the most popular products in the class, Prempro, Premphase, and Prem-arin, all manufactured by Wyeth (Madison, NJ), and is requesting that other manufacturers of such products make similar labeling changes. The products are used for relief of menopausal symptoms and prevention of postmenopausal osteoporosis.

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