Ask Doctors About Hormone Therapy, FDA Tells Women

Millions of post-menopausal women who are confused about whether to continue hormone replacement should consult with their doctors, the government said Wednesday.

The Food and Drug Administration issued that guidance, and it announced new labeling requirements for estrogen and estrogen with progestin products, after reviewing data from a landmark study that raised concerns about the risks of using the popular pills.

That study, sponsored by the National Institutes of Health, was halted abruptly in July after researchers found that the risks, particularly increased risk of heart attacks and breast cancer, from long-term use of the hormone replacement products outweighed the health benefits.

FDA Commissioner Scott McClellan said the agency was issuing revised consumer labeling to reflect the study findings and requiring all makers of estrogen and estrogen with progestin products, including patches and topical medications, to update their product labels.