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9/9/2003

FDA Launches Hormone Therapy Education Campaign

Kate Traynor

Food and Drug Administration (FDA) Commissioner Mark B. McClellan today announced the creation of an educational campaign designed to increase the awareness of health care providers and the public about the risks and benefits of menopausal hormone therapy.

"Menopausal hormone therapy is a major personal decision for women, and they should be armed with the latest facts and useful tools to make the best decision for their needs," McClellan said during a press conference on Capitol Hill. To this end, FDA's Office of Women's Health has teamed with other Department of Health and Human Services agencies and medical and patient groups to launch the Menopausal Hormone Therapy Information Campaign.

The campaign's public-information centerpieces are a fact sheet on menopause and hormone therapy and a smaller "purse guide" with questions that women who are considering hormone therapy should ask their health care providers. Both documents are available in English and Spanish.

"These materials let women know that menopausal hormone therapy works to reduce hot flashes and night sweats, to treat vaginal dryness, and to slow bone loss," McClellan said. "Working with their health care providers, women need to weigh these important benefits against the recent finding of increased risk of heart disease, stroke, breast cancer, and some other concerns associated with the use of menopausal hormones."

Information and educational materials associated with the campaign are also available online at the National Women's Health Information Center.

Joining McClellan were Reps. Henry Bonilla (R-Tex.) and Rosa DeLauro (D-Conn.), whose efforts to boost the campaign included an increase of $600,000 in next year's federal budget appropriations for FDA's Office of Women's Health. Much of the funding is earmarked for outreach campaigns on hormone therapy and other issues that affect women's health. According to FDA, today's campaign launch is part of a series of efforts that will continue this fall.

Bonilla called menopausal hormone therapy "one of the most important medical issues that we will deal with in our lifetime." The issue became increasingly prominent over the past year as findings from the federally funded Women's Health Initiative (WHI) revealed that many presumptions about the protective effects of estrogen and progestin replacement are false, and that the therapy significantly increases women's risk of breast cancer and cardiovascular events.

"There has been a considerable amount of uncertainty and worry following the release of new study findings" from WHI, McClellan said. "Our hope, with the leadership of Congress on this issue, is to be able to get accurate information out."

McClellan emphasized that the initiative is a "two-pronged approach" involving both women and health care providers.

"A main focus of this initiative is to help reach health care professionals and help encourage appropriate communication with health care professionals," McClellan said. He added that the goal is for women to ask the right questions and thus receive the appropriate treatment for their individual needs.

FDA recently revised the labeling for hormonal therapy products on the basis of WHI findings.

"All manufacturers of hormone therapy have cooperated with us in implementing the labeling changes, and many of them are undertaking their own activities to help get the word out to women," McClellan said. Labeling changes have included informing women that they should use the least amount of hormone for the shortest period of time to relieve their symptoms.

McClellan noted that his agency has no plans for now to require additional labeling changes but added that FDA will "continue to monitor the latest information available from ongoing studies about menopausal hormone therapy to make sure that our label stays up-to-date."