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FDA-Approved Bioidentical Hormones for Menopause

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Q

I’m 50, getting hot flashes, and I’m interested in bioidentical hormones. Where can I get them?

A

There are actually two ways to get bioidentical hormone therapy (BHRT)—through FDA-approved prescriptions or through a compounding pharmacy. The first choice is much safer.

First, though, let’s step back and explain what bioidentical hormones are. They are hormones that are manufactured to have the same chemical structure as the ones that are produced by women’s bodies. The primary form of estrogen that women make in their ovaries is estradiol. FDA-approved Premarin, the most common prescription hormone treatment in the US, is not bioidentical—it is 17% estradiol but also contains dozens of other compounds. In contrast, bioidentical hormones can be produced that contain nearly 100% estradiol. Some are derived from plant sources, such as a special kind of yam. Some studies suggest that they are better for women’s health—for example, by not raising the risk for breast cancer, cardiovascular disease or cognitive issues as much as Premarin does—but the research is not conclusive. I believe they are comparable in risk.

The good news for women who make this choice is that there are many FDA-approved bioidentical hormone products that supply estradiol that you can buy…with a prescription, of course…at any neighborhood pharmacy. They have names such as Estrace, Alora, Climara, Estring and Vagifem. A woman who still has her uterus and who goes on hormone therapy for menopause symptoms should also take progesterone to reduce her risk for uterine cancer. FDA-approved bioidentical progesterone products, such as Prometrium, are available as well. (At present, there are no combined estrogen/progesterone prescriptions that are bioidentical, except for pharmacy-compounded ones, but they are in development.)

The other type of place where you could get bioidentical hormones is a compounding pharmacy. This type of pharmacy makes medication to order based on health-care providers’ specific instructions. You might assume that custom-compounded drugs would be ideal, since they’re made to order, but in fact they aren’t approved by the FDA…and experience has shown that their quality varies widely. In fact, you might not get what your doctor ordered. Research in the last years has found this can lead to serious health problems. Example: In one study, researchers had 12 different compounding pharmacies fill the same prescription, then had each filled prescription analyzed at a chemical lab. It turned out that estrogen was provided by these pharmacies at doses of as much as 173% more than what had been prescribed, and progesterone was provided at doses of up to 40% less than what had been prescribed. Because of the incorrect estrogen/progesterone ratios, taking such incorrectly filled prescriptions could lead to a condition called hyperplasia, an increase in cell production that can lead to uterine cancer—and that is just one of the potentially serious outcomes that could possibly result from incorrectly compounded hormones.

I would encourage you to choose FDA-approved hormones. If you’re set on the path of compounded hormones, though, I’d recommend that you have your uterine lining checked once a year for abnormality. Most health-care providers who prescribe these compounds will do this with a biopsy or ultrasound—and if the ultrasound reveals that the thickness of the uterine lining is more than four millimeters, you’ll need a biopsy anyway, regardless of whether you are using hormone therapy. It’s also a good idea to seek out a compounding pharmacy that is accredited by the Accreditation Commission for American Health Care. That’s helpful, although it’s no guarantee.

Bottom line: If you want bioidentical hormones, stick with the FDA-approved drugstore preparations. You can get patches, gels, creams, sprays and pills in a wide variety of doses. Talk to your doctor about which one is best for relief of the menopause-related symptoms that bother you the most. These products are regulated, so you and your doctor will know exactly what you’re getting.

Source: Mache Seibel, MD, leading expert on women’s health and menopause, is a member of the faculty at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. He is the editor of The Hot Years: My Menopause Magazine, and author of The Estrogen Fix: The Breakthrough Guide to Being Healthy, Energized, and Hormonally Balanced. DrMache.com Date: October 18, 2017 Publication: Bottom Line Health
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