The Endocrine Society has issued a statement advising clinicians to avoid administering compounded hormone medications to treat menopausal symptoms, female sexual dysfunction, and other hormone conditions. Compounded hormone medications, also known as bioidentical compounded hormones, are intended to be alternatives when patients do not have access or experience adverse reactions to FDA-approved medications.

Despite the availability of FDA-approved hormone treatments, which are 100% chemically identical to native bodily hormones, millions of women still use compounded hormones. Many believe the misconception that compounded menopausal hormone therapy (MHT) is safer than the FDA-approved treatments and use it to treat menopausal symptoms (eg, hot flashes, not sweats). 

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The safety of compounded hormones is questionable and limited by an oversight in quality. In 2010, 60 deaths from fungal meningitis were attributed to compounded medications. “Advertisers have marketed compounded products as being able to prevent the ravages of aging and implied they are risk free, few, if any, of these claims are supported by science,” said Nanette Santoro, MD, and chair of the Society task force who wrote the statement.

According to the statement, there is no scientific or medical reason to use a custom-compounded treatment that could have an unknown effect on the body when there are many FDA-approved options for treating menopausal symptoms. As of now, there have been no large-scale, long-term studies conducted to examine the effectiveness and safety of custom-compounded MHT.

Concerns have been raised in the past regarding MHT, though experts formed a consensus that the benefits of MHT outweigh the risks for most healthy women. Research over the last decade has found that the risk level is dependent on individual factors such as health, history and age. Women who use a customized preparation of estrogen and/or progestin may be at risk of an overdose or an ineffective result due to under-dosing. 

The statement reiterated that scientific studies do not support the use of testosterone or dehydroepiandrosterone (DHEA) therapies for women experiencing sexual dysfunction. For thyroid disorders, FDA-approved medications remain safest and most effective compared to any compounded medications.

“Custom-compounded hormones should be reserved for situations in which a patient is allergic to or does not tolerate any of the FDA-approved therapies, and treatment is necessary for his or her health,” said Dr. Santoro.

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