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Government-approved Drugs for Menopause

A wide variety of government-approved prescription therapies are available for menopausal symptoms in the United States and Canada. These include estrogens and progestogens as well as two recently approved nonhormonal therapies. With these well-tested, government-approved options, prescribers can meet the need to control vasomotor and vulvovaginal atrophy symptoms effectively while minimizing risk and accommodating women’s personal therapy preferences.

Since the initial release of results from the Women’s Health Initiative (WHI) trials in 2002, which raised concerns about the safety of menopausal hormone therapy when used for prevention of chronic diseases of aging, use of oral hormone therapy formulations has declined while that of transdermal formulations has remained stable and vaginal formulations has grown.1
Current use (prevalence) and new initiation (incidence) of hormone therapy by formulation in the database of a large pharmacy benefit manager (Medco Health Solutions Inc., Franklin Lakes, NJ). Annual (January-December) prevalence of women using hormone therapy by formulation and percent of women starting hormone therapy by formulation shown as a percentage of all eligible women 50 years and older.1 (From Steinkellner et al. Menopause. 2012;19:616-621.)


As a result of these concerns, many women choose to forgo medical therapy while others seek alternatives they perceive as safer or more “natural,” including compounded “bioidentical hormone replacement therapy.” With the help of NAMS menopausal therapy tables and other resources, providers can learn about evidence-based systemic and intravaginal hormone prescribing for menopausal symptoms and about government-approved nonhormonal alternatives as well as about compounded hormone therapy so they can help their patients understand the risks and benefits of each approach.

The tables will also help providers demonstrate that, although the term “bioidentical” is often used to refer only to custom-compounded hormones, many well-tested, government-approved hormone formulations are bioidentical, meaning compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body.2

Click on the link below to see tables listing all the government-approved therapies for menopausal symptoms in the United States and Canada. Please note that inclusion does not imply that NAMS endorses the products listed in these hormone therapy tables.

Providers should check the full prescribing information for any updates and for information that is not provided here, such as warnings and contraindications.

VIEW THE TABLES

1. Steinkellner AR, Denison SE, Eldredge SL, Lenzi LL, Chen W, Bowlin SJ. A decade of postmenopausal hormone therapy prescribing in the United States: long-term effects of the Women’s Health Initiative. Menopause. 2012;19:616-621.

2. FDA. Compounded Menopausal Hormone Therapy Questions and Answers. Available at: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm183088.htm. Accessed January 13, 2014.

 

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