Truth About Compounded Bioidentical Hormones

Ruzanna Harutyunyan's picture
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Women in, or past, menopause who use specially compounded "bioidentical" hormones to treat menopause-related symptoms, such as hot flushes, often don't get adequate information from compounding pharmacists about the drugs' risks and realistic potential for benefit. That's one of the concerns about these medications addressed by menopause expert JoAnn V. Pinkerton, MD, in "'Bioidentical' hormones: What you (and your patient) need to know," in the January issue of OBG Management.

So-called bioidentical hormones are chemically similar to hormones released by the body, including those produced in the ovaries -- estrone, estradiol, estriol, progesterone, testosterone, and dehydroepiandrosterone, to name some.

"The FDA has approved many prescription products that contain 'bioidentical' hormones," says Pinkerton, "but 'bioidentical' is often used to refer to custom-compounded hormones. The major difference between FDA-approved prescription bioidentical hormone products and custom-compounded products is that only the former are regulated by the FDA and tested for purity, potency, efficacy, and safety."

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"That means it's up to physicians who prescribe compounded hormones to educate their patients -- about potential risks and benefits, absence of FDA oversight, purity and potency concerns, and lack of peer-reviewed data on efficacy and safety," Pinkerton says.

"Practitioners need to recognize that women who ask for these hormones may be vulnerable -- because of anxiety and depression that often accompany menopausal symptoms -- to unsubstantiated claims or recommendations of self-proclaimed experts."

"Compounded hormones aren't safer, or more effective, than traditional FDA-approved hormone therapies," Pinkerton emphasizes. "No data support individualized, personalized therapy based on testing hormone levels in saliva. And compounded bioidentical hormones don't prevent cancer; they probably have the same potential to cause cancer, and present the same other health risks, as FDA-approved hormones."

Bioidentical hormones are one of the biggest products of the multibillion-dollar US pharmaceutical compounding industry, observes Bruce Patsner, MD, JD, who contributed to the OBG Management article. Patsner, an expert on pharmacy compounding of prescription hormone therapy, served as senior medical officer at the FDA and is now Research Professor of Law at the University of Houston Law Center.

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