With commentary by Nanette Santoro, M.D., task force chair and professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine.
Doctors should avoid prescribing compounded hormone medications to treat menopausal symptoms, female sexual dysfunction and other hormonal conditions, according to a recent scientific statement by the Endocrine Society.
“Custom-compounding has turned into an industry that is much less tightly regulated than FDA-approved pharmaceuticals,” said Nanette Santoro, M.D., chair of the task force that developed the statement and professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine. “Many claims of efficacy and safety are being made for bioidenticals, but there are no data to support them one way or the other."
Use of custom-compounded bioidentical hormones has surged in recent years. Between 28% and 68% of women who take hormones at menopause use compounded bioidentical hormones, according to surveys published in Menopause, the Journal of the North American Menopause Society. The formulas—offered as pills, patches, sprays, gels and creams—are prescribed by doctors and prepared by compounding pharmacies to treat hot flashes, night sweats and vaginal dryness.
Patients as well as doctors turned toward bioidentical hormone therapy (BHT) as a safe alternative to traditional hormone replacement therapy (HT) after the large-scale clinical trial known as the Women’s Health Initiative (WHI) found in 2002 that Prempro—the top-selling HT drug containing synthesized pregnant mares’ urine and a progesterone derivative—significantly increased the risk of heart attack, stroke, blood clots and breast cancer.
As a result of the WHI’s findings, the FDA required manufacturers to add a “black-box” warning1—the strongest in prescription labeling—to Prempro and Premarin (another HT top-seller, similar to Prempro but without the progesterone) as well as to all FDA-approved drugs containing estrogens and progestogens.
The issue with custom-compounded bioidenticals, some say, is that because the products are not subject to FDA’s approval process, they don’t bear the warnings they should. “There is no reason to expect that custom compounded hormones have different risks or benefits than FDA approved ones,” Dr. Santoro said. “The lack of evidence of harm is promoted as evidence of safety, and that’s just faulty logic.”
One popular BHT prescription calls for a blend of three forms of bioidentical estrogens (estradiol, estrone and estriol) along with progesterone. While the first two ingredients are FDA-approved, estriol is not because it has never undergone clinical tests in the U.S. Critics also say that compounded BHT preparations are of unreliable potency and that there can be significant variation in a medicine’s content from pill to pill, exposing women to potentially risky doses and combinations of hormones.2,3
Proponents of compounded bioidenticals say that the products are natural and plant-based (many of the formulas are derived from wild yams, for example), and that they can be customized to fit a woman’s particular needs. Compounded BHT products may also be nearly identical to prescription hormone products (same drug, different inactive ingredients) while offering a cost benefit: Estradiol 0.01% vaginal cream can be compounded to provide a less-expensive alternative to Estrace 0.01% vaginal cream.4
Meanwhile, experts point out that custom compounded and bioidentical are not one in the same. “We have many FDA-approved bioidentical hormone products,” said James A. Simon, M.D., professor of obstetrics and gynecology at George Washington University School of Medicine. “These products have extensive package inserts with efficacy and safety clearly delineated.”
To date, there are no randomized, controlled trials comparing bioidentical compounded hormonal therapies with placebo or with FDA-approved therapies. Studies have found however, that women report their sexual symptoms are more frequently relieved by bioidentical compounded hormone therapy than by conventional hormone therapy.5
“The patient has the choice to opt for a compounded medication, and that decision should be made with a physician,” said Dagmar Anderson, vice president of communications at the International Academy of Compounding Pharmacists in Missouri City, TX.
For those who choose to use compounded BHT, pharmacists and doctors recommend working exclusively with accredited compounding pharmacies, listed on the website of the Pharmaceutical Compounding Accreditation Board (PCAB).6