FDA Unveils Web Site To Provide Women With Information on Hormone Replacement Therapy
The FDA on Tuesday unveiled an educational campaign on the HHS National Women's Health Information Center's Web site to raise awareness of the risks associated with hormone replacement therapy and to put those risks into an accurate context, the Washington Post reports (Kaufman, Washington Post, 9/10). The information will also be distributed by several women's health groups (AP/Las Vegas Sun, 9/9). In July 2002 federal health officials terminated some sections of the Women's Health Initiative research project testing the benefits of HRT three years early because researchers determined that HRT may increase the risk of invasive breast cancer and other diseases. Since then, an NIH study has also found that HRT does not stave off dementia (California Healthline, 5/28). Another analysis found that HRT increases a woman's risk of having a heart attack (California Healthline, 8/7). In light of the findings, Congress in the spring mandated the creation of an educational campaign, and the FDA convened representatives from 29 organizations -- including the American College of Obstetrics and Gynecologists, the American Heart Association and the North American Menopause Society -- to summarize the latest information and help guide women through the decision-making process (Rubin, USA Today, 9/10). The group has produced an educational guide that emphasizes that women who decide to take the hormones to relieve menopausal symptoms including hot flashes and vaginal dryness, which have "few proven alternatives," should take the lowest dose for the shortest time possible and should discuss their risk factors with their physicians, the Post reports (Washington Post, 9/10). The guide includes a two-page fact sheet and a list of questions that women can ask their health care providers, such as whether HRT is appropriate for them and how they should stop the treatment if they decide they no longer want to take HRT (USA Today, 9/10).
FDA Commissioner Mark McClellan said, "Postmenopausal hormone therapy is a major, personal decision for women, and they should be armed with the latest key facts and useful tools to make the best decision for their needs" (FDA release, 9/9). He added that the group writing the guide sought a "reasoned and not an alarmist message" about HRT. Phyllis Greenberger, president of the Society for Women's Health Research, said that women should be informed of the magnitude of the risks of HRT. About one-tenth of one percent of women experience dangerous side effects from HRT, she said (Washington Post, 9/10). However, the specific risks vary from woman to woman, Reuters/Arizona Daily Star reports (Reuters/Arizona Daily Star, 9/10). Diana Zuckerman, president of the National Center for Policy Research for Women and Families, said there were "some real battles over the wording" of the guide between groups saying that women should be reassured that the risks are small and others saying that the risks should be given equal weight as the benefits. Zuckerman added that the guide is "a kind of an uneasy compromise" (Washington Post, 9/10).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.