U.S. Food and Drug Administration
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Menopause and Hormone Replacement

In recent months and years, there has been a great deal of confusion concerning menopause and hormone replacement therapy (HRT). The FDA regulates the drugs that make up different kinds of HRT, and has changed information on drug labels as new scientific information becomes available.

Information from the FDA

Bio-Identicals: Sorting Myths from Facts (Consumer Article)

Menopause & Hormones: A Web portal that links to the latest information.

Menopause and Hormones (Fact Sheet, July 2005)

La menopausia y las hormonas (Spanish-language Fact Sheet, July 2005)

Menopause and Hormones (Purse Guide--Questions for doctor)

La menopausia y las hormonas ¿Qué podemos creer? (Spanish-language purse guide and questions for doctor)

FDA Updates Hormone Therapy Information for Post Menopausal Women (Press Release, 2-14-2004)

Home-Use Tests--Menopause
Center for Devices and Radiological Health

Menopausal Hormone Therapy (FDA Consumer magazine)
Discusses recent findings from the Women's Health Initiative Study, the risks and benefits of menopausal hormone therapy

FDA Approves New Labeling and Provides New Advice to Postmenopausal Women Who Use or Who Are Considering Using Estrogen and Estrogen With Progestin (FDA Fact Sheet)

Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women
Includes updated labeling.

The Estrogen and Progestin Dilemma: New Advice, Labeling Guidelines (FDA Consumer magazine)

Updated Labeling for Estrogen and Estrogen-Progestin Products for Postmenopausal Women
Includes approved labeling for Prempro and Premarin
Center for Drug Evaluation and Research

Safety-Related Labeling Changes for Prempro
MedWatch

FDA Approves New Labels for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women Following Review of Women's Health Initiative Data (Press Release, 1-8-2003)

FDA Statement on the Results of the Women's Health Initiative (8/13/2002)
Center for Drug Evaluation and Research (CDER)

FDA Approves Lower Dose of Prempro, a Combination Estrogen and Progestin Drug for Postmenopausal Women (Press Release, 3-13-2003)

Drugs@FDA: This site allows users to research the safety and effectiveness of various medications that might be used to manage symptoms of menopause.

Information from Other Government Agencies

Menopause Information Kit
Free information in English and Spanish.
Federal Citizen Information Center

Menopausal Hormone Replacement Therapy Information
Findings from the Women's Health Initiative Study and other information (includes news from April 2006)
National Institutes of Health (NIH)

Menopause and Hormone Therapy: Online resource center
National Women's Health Information Center

Menopausal Hormone Therapy (and Heart Disease)
National Heart Lung and Blood Institute (NHLBI) at the National Institutes of Health

Information on Hormone Replacement Therapy
Medline Plus, National Library of Medicine, National Insitutes of Health

rule Office of Women's Health link to FDA home page link to U.S. Department of Health and Human Services FDA logo--link to FDA home page