Newswise — In 2002, a clinical trial found that the harmful side effects of a traditional hormone therapy combination outweighed the benefits for chronic disease prevention in postmenopausal women. Instead of those therapies (marketed as Premarin and Provera), many women now use bioidentical hormone therapy to reduce hot flashes and other postmenopausal symptoms. These estradiol tablets, patches and gels, and progesterone capsules are FDA-approved.

However, millions of other women, put off by the 2002 findings and often prompted by celebrity endorsements, have also turned to an alternative they are told is “natural,” effective and safe: compounded bioidentical hormone therapies (cBHTs).

Here, a doctor still writes a prescription, but instead of a standard medication off of the pharmacy shelf, a compounding pharmacy makes up the prescribed, personalized formula for the patient. Compounding pharmacies play an important role in health care, especially for patients intolerant or sensitive to a particular component of an FDA-approved medication. They are regulated by state pharmacy boards and while their made-to-order formulations are legal, they are not FDA-approved.

“The thing is, cBHTs should be made up of the same bioidentical hormone ingredients as the FDA-approved therapies, but they don’t have the same manufacturing oversight or standardization in content, purity and consistency,” said Cynthia Stuenkel, MD, an endocrinologist and clinical professor at UC San Diego School of Medicine and women’s health advocate.

Recent surveys by the North American Menopause Society and others found that cBHT is prevalent in the U.S. One patient survey estimated that 1 to 2.5 million women in the U.S. 40 years or older used cBHT. Another survey determined that 50 percent of women taking cBHT mistakenly thought it was FDA-approved.

In a commentary published October 9 in JAMA Internal Medicine, Stuenkel and JoAnn Manson, MD, DrPH, of Bingham and Women’s Hospital and Harvard Medical School, call for improved oversight and transparency for cBHTs.

“We’re not saying women shouldn’t take compounded hormone therapies, but we do think they should know what they are, what the potential risks are, and that FDA-approved therapies are readily available,” Stuenkel said. “At the very least, cBHT products should come with labeling or inserts that explain that they are not FDA-approved and that the risks are unknown or expected to be the same as those of FDA-approved bioidentical hormone therapies.”

At UC San Diego Health, Kathryn Macaulay, MD, professor of reproductive medicine, and pharmacist specialist Sally Rafie, PharmD, work closely to determine how best to help perimenopausal and postmenopausal women with symptoms that warrant medical treatment. FDA-approved bioidentical hormone therapies are their first choice. But many patients seek their advice about cBHT, and some are already taking a cBHT when they come to UC San Diego Health.

Rafie says listening to patients’ values and providing education about the benefits and risks is critical. “A woman knows her own body best and we help her make informed decisions about hormonal and non-hormonal therapies that are safe for her to use,” she said.  

In the infrequent case that cBHT is the best therapy for a patient, the UC San Diego Health care team can help her take it safely. One way they do this is by monitoring blood hormone levels, to make sure she’s not getting too much.

“For the majority of these patients, the information we give them about cBHT is new … and many say that they were never told there are FDA-approved bioidentical hormones available,” Macaulay said, underscoring Stuenkel and Manson’s call for better cBHT labeling and education.