FDA requires new labels on HRT products

Thursday, January 9, 2003

WASHINGTON -- The government announced new warnings Wednesday on the labels for hormone replacement therapies and advised millions of post-menopausal women to consult their doctors about whether to continue treatment.

The Food and Drug Administration acted after reviewing data from a landmark study that found that the increased risk of heart disease and breast cancer from using therapies combining the hormones estrogen and progestin far outweighed any health benefits. The government abruptly halted that study last July.

The FDA approved new labels for Wyeth Pharmaceuticals that includes a new boxed warning highlighting the increased risk for heart disease, heart attacks, strokes and breast cancer. They also include a reference to the study findings.

The new labels also emphasize that these products are not approved for the prevention of heart disease.

The FDA also said it was asking all manufacturers of estrogen and estrogen-progestin products to add similar warnings and change the enclosed patient information leaflet because all hormone products are believed to carry similar health risks.

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