FDA offers new guidelines on hormone replacement therapy

By Advocate.com Editors

Originally published on Advocate.com January 10 2003 1:00 AM ET

The Food and Drug Administration on Wednesday released new guidelines for hormone replacement therapy for women undergoing or past menopause, The Washington Post reports. The new guidelines say hormones can be taken to alleviate hot flashes and vaginal dryness and to prevent osteoporosis in those at risk for the condition, but the lowest possible doses of hormones should be given and should be taken for the shortest possible time. Women also should explore other treatment possibilities before opting for hormone therapy, according to the guidelines. Hormones should not be taken to reduce the risk of heart disease.

The federal guidelines are the first to be published following the release of studies last summer that showed that estrogen and progesterone therapy actually may boost the risk of heart attacks, stroke, breast cancer, and blood clots. An ongoing National Institutes of Health study also was stopped because preliminary data showed that hormone therapy increases health risks for many women. Based on those studies, the FDA on Wednesday also ordered that all products containing estrogen carry prominent label warnings that extended use can lead to those conditions.

"The main message that women need to take away is that the decision about hormone use is a decision that needs to be individualized," said FDA commissioner Mark McClellan. "There are clear benefits and clear risks associated with estrogen. Our goal in this guidance is to help women and their health care providers make informed decisions about the risk and benefits."