What does compounded bio-identical hormone replacement therapy (BHRT) mean to you? To some, including Suzanne Somers [1], it is the best thing since sliced bread. To others it's a ticking time bomb. Regardless of what side of the fence you're on, it is still important to understand the potentially serious consequences of taking compounded bio-identical hormones.
Compounded BHRT refers to natural or bio-identical hormones, which are mixed in differing combinations, and then prepared into topical creams, gels, lotions, tablets, and suppositories [2]. Because these products are created on a patient-by-patient basis, each one of them contains slightly different dosages -- meaning the Food and Drug Administration (FDA) has no way to regulate them. The final products are not submitted to the FDA and therefore do not have approval for their safety and effectiveness, as they are not subject to clinical trials.
Most women are unaware that these products are not FDA-approved. In fact, according to a survey published earlier this year by the North American Menopause Society (NAMS), when asked, "Do you believe that bio-identical hormone therapies compounded at a specialty pharmacy are FDA-approved?" Only 14 percent of women correctly answered "no." Most -- 76 percent -- weren't sure, and 10 percent incorrectly answered "yes." [3]
Before considering custom-made hormones, women should be mindful of the history behind these products. In 2001, the FDA collected and analyzed 29 compounded drugs, including eight hormone drugs. Two out the 10 drugs were compounded hormone drugs, which failed analytical tests because of contamination risks [4]. In 2005, a citizen petition was filed that requested the FDA initiate enforcement actions against pharmacists compounding BHRT or promoting the drugs, and determine if proper labeling could be required with these products. The Endocrine Society and the American Medical Association later called for increased regulatory oversight of these products.
In 2007, the Medical Journal of Australia published an article [5] detailing three women who developed endometrial cancer after taking BHRT. Later the FDA developed the brochure, "Bio-Identicals: Sorting Myths from Facts," which outlined various false claims and statements about bio-identical hormones, and to send warning letters to seven pharmacy operations regarding the claims they were making about their products [6].
In 2012, with partial funding from the Fund for Investigative Journalism, More magazine commissioned lab tests of bio-identical hormones produced by 12 compounding pharmacies nationwide, and it was revealed that these hormones were of unreliable potency, and that they would not come close to meeting the FDA's requirements for commercially manufactured drugs. In fact, the doses in the pills tested fluctuated in a way that could increase the risk of uterine cancer [7].
Despite the alarming history, compounded BHRT products are still marketed as "all natural" and safer alternatives to standard hormone replacement therapy. This advertising has been a result of the Women's Health Initiative (WHI) studies, which were terminated in 2002, when it appeared that the use of hormone therapy (HT) had actually increased the risk of heart disease and breast cancer, for some women participating in trials. Even though it later became known that the WHI studies were limited in terms of telling us about the effects on post-menopausal women, the negative publicity surrounding the findings has boosted the popularity of compounded BHRT products.
Today, BHRT products make up nearly 40 percent of all menopausal hormones used in the U.S. and cost women one to two billion dollars annually [8]. Of the 57 to 75 million prescriptions filled for all menopausal hormone therapies annually, 36 million of those prescriptions are written for FDA-approved hormone therapy, with the remaining 28 to 39 million prescriptions written specifically for compounded bio-identical hormones [9]. Similar numbers were also found in a study that was reported at the Endocrine Society meeting here. However, much of the marketing for compounded BHRT contains inaccurate information and does not adequately advise patients and their healthcare providers of the risks associated with these products.
SWHR encourages the FDA to continue their surveying of these products, and urges women to remember that these products do not have FDA approval for safety and effectiveness. For women who are currently receiving or considering hormone replacement therapy, speak with your healthcare provider to determine what option works best for you, given your family and medical history.
Visit SWHR.org to learn more about compounded BHRT.
References
4. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm