The term “bioidentical hormone therapy” began as a marketing term for custom-compounded hormones. The term now usually refers to compounds that have the same chemical and molecular structure as hormones that are produced in the body, the definition that NAMS uses.
Bioidentical hormones do not have to be custom-compounded (meaning custom mixed). There are many well-tested, FDA-approved hormone therapy products that meet this definition and are commercially available from retail pharmacies.
Government-approved hormones and other menopausal therapy products in the United States and Canada (includes all approved products that meet the above definition of bioidentical)
Indeed, the concern about the use of bioidentical hormone therapy is really about custom-compounded recipes prepared by a pharmacist following an individual prescriber’s order for a specific patient. These medications do not have FDA approval because individually mixed recipes have not been tested to prove that the active ingredients are absorbed appropriately or provide predictable levels in blood and tissue. Furthermore, there is no scientific evidence that these compounded medications are safer or more effective than government-approved hormones.
Compounders often rely on salivary and blood tests to “assess” your hormone levels to mix their recipes, but these tests are meaningless for midlife women because hormone levels vary from day to day and even from hour to hour.
NAMS supports the actions of the US Congress, FDA, and other scientific organizations that have warned about the potential harm from compounded bioidentical hormones.
Learn more about these issues at these links.
- What Is Custom-Compounded Therapy?
Custom-compounded hormones may provide certain benefits…but there may be risks to the
consumer, too. - FDA Answers Questions about Compounded Menopausal Hormone Therapy
FDA addresses questions about compounding, its risks, and the agency’s actions and positions. - What Is Hormone Testing?
Menopausal hormone levels vary throughout the day, as well as from day to day. NAMS does not recommend hormone level testing. - The Hormone Hoax Thousands Fall For
This investigative report in More magazine showed that not one of the custom-compounded hormone mixtures tested contained the prescribed amounts, potentially raising the cancer risk. - US Government Takes Action
FDA and the US Congress have taken action to curb false and misleading claims about bioidentical hormone therapy and to make compounded drugs safer. - NAMS Endorses Endocrine Society Statement
Little or no scientific or medical evidence supports claims that bioidentical hormones are safer or more effective than more traditional FDA-approved therapies. In addition, many custom-compounded “bioidentical hormone” formulations are not subject to FDA oversight and can be inconsistent in dose and purity. (2006, re-released in 2009) - “Compounded Bioidentical Hormones: What’s the Harm?”
There has been a clear lack of medical evidence supporting either the efficacy or safety claims of “individualized” prescription drugs. Transcript and slides by Bruce Patsner, MD, JD (2008) - “Understanding the Controversy: Hormone Testing & Bioidentical Hormones”
Postgraduate Course Monograph on Bioidentical Hormones
Was a comprehensive course presented by experts in the field. (2006) - Dr. Nese Yuksel and Dr. JoAnn Pinkerton talk about bioidentical hormones at the NAMS 2014 Annual Meeting. (2014)