During menopause, you may experience hot flashes, vaginal dryness and thin bones (osteoporosis). To help with these problems, you may take estrogen, or estrogen combined with another hormone, progestin. This is called menopausal hormone therapy (MHT), and it’s approved by the FDA.
A major research study, the Women’s Health Initiative (WHI), shed new light on the safety of FDA-approved MHT used to relieve symptoms. Because of these findings, some women have been seeking options other than traditional FDA-approved hormone therapies. These alternative therapies include a category of hormones that are promoted as bioidentical to the hormones produced by your body, and the phrase bioidentical hormone therapy (BHT) is being used to sell and describe these drugs.
Are bioidenticals commonly used?
Exactly how often bioidenticals are used, prescribed or compounded is unknown. Unlike commercial drug manufacturers, pharmacies engaged in traditional pharmacy compounding generally aren’t required to register with the FDA, or to list the drugs that they produce. There is no way to track the number of healthcare practitioners who prescribe bioidenticals or the number of women who use them. Reports from consumers and healthcare practitioners and Internet surveillance lead us to believe that this is quite common practice and that it’s increasing.
Bioidenticals
The term bioidentical has no defined meaning in any medical or conventional dictionary. Even different medical groups define the term differently. The Endocrine Society, for example, defines bioidentical hormones as compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body, while the American College of Obstetricians and Gynecologists (ACOG) defines bioidentical hormones as plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.
Bioidentical is used as a marketing term to sell these products and to imply that bioidentical drugs are natural, have identical effects as the hormones made by the body or are in some way safer than approved MHTs. Bioidentical hormone therapy, or BHT, is available in various dosage forms such as pills, creams, lotions or gels. These products are often sold at pharmacies based on a prescription from a healthcare provider. They may also be sold over the counter, without a prescription. Some BHT drugs are compounded in pharmacies.
Pharmacy compounding: Making BHTs
Traditional pharmacy compounding is the combining, mixing or altering of ingredients by a pharmacist to produce a drug tailored to your special medical needs in response to a licensed medical practitioner’s prescription. Traditional compounding is an important component of healthcare and enhances treatment with individually tailored drugs when a healthcare provider determines that an FDA-approved drug may not be available or appropriate for your care.
In its simplest form, traditional compounding may involve taking an approved drug and making a new formulation without a dye or preservative in response to a known allergy. For example, in the case of MHT, the FDA-approved progesterone product contains peanut oil. Progesterone compounded without peanut oil in response to a prescription for a woman who is allergic to peanut oil might allow her to safely use the drug.
The unique tailoring of a compounded drug for your specific care makes it impossible for compounded drugs to be reviewed by the FDA the way that drugs made by most commercial pharmaceutical companies are. While compounded drugs may meet specific medical needs, they lack the assurance of safety and efficacy that is required for FDA approval.
Are there problems with compounded BHTs?
Drugs that are approved by the FDA must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug to ensure its safety and effectiveness—from early testing, to the design and results of large clinical trials, to the severity of side effects, to the conditions under which the drug is manufactured. MHT drugs have undergone this process and met all federal standards for approval. Compounded drugs, including BHT, are not FDA-approved, in part because they’re usually made on a patient-by-patient basis, in small amounts for that person, in response to a prescription.
Pharmacies that compound drugs may not follow drug manufacturing requirements that apply to commercial drug manufacturers. Some pharmacies may use unsafe or poor-quality compounding practices. Compounded drugs may be sub- or super potent, contaminated or produced in violation of drug manufacturing requirements. Compounding pharmacies custom-mix these products according to a healthcare professional's order.
This mixture contains not only the active ingredient, but also other inactive ingredients that help hold a pill together or give a cream, lotion or gel its form and thickness so that it can be applied to the body. Because these mixtures are not FDA-approved, it’s unknown whether they are properly absorbed or provide the appropriate levels of drug needed in the body. It’s also unknown whether the amount of drug delivered is consistent from pill to pill or each time a cream or gel is applied. In contrast, this type of consistency is required of all commercial drug manufacturers, including those who make MHT.
Compounded BHT usually contains estrogen and progesterone and, in some cases, may contain testosterone or an estrogen component called estriol. No drug containing estriol has ever been approved by the FDA, and the safety and effectiveness of estriol isn’t known. The use of a drug that has neither been approved by the FDA nor is the component of an FDA-approved drug may pose a danger to women’s health.
False claims with bioidenticals
Some pharmacies that compound BHT drugs have made false claims that BHT drugs are more effective and safer than MHT. These claims aren’t supported by research. There is no credible scientific evidence that shows the safety, efficacy or superiority of compounded BHT. This is concerning because women and healthcare practitioners are being misled.
A number of pharmacies claim that compounded BHT can prevent, treat or even cure serious illnesses including heart disease, stroke, depression, Alzheimer’s disease, osteoporosis, breast cancer and colon cancer. Yet there’s no credible scientific evidence that BHT can be used to prevent or treat any of these illnesses. In fact, just like MHT, it’s expected that BHT has the same benefits and risks associated with hormone therapy and there’s no reason to believe that they will be safer.
The FDA has issued warning letters to pharmacies that make false and misleading claims about compounded BHT drugs, including claims that compounded BHT drugs are safer or more effective than MHT drugs and claims that compounded BHT drugs can prevent or treat serious illnesses.
Just because they are considered natural doesn’t mean that the bioidentical hormones are safe or safer. Several medical professional associations, including the Endocrine Society, the North American Menopause Society (NAMS) and ACOG, have issued advisories supporting the belief that all hormone therapies—bioidentical or otherwise—carry the same risks.
Some compounding pharmacies and other promoters of BHT claim these products are better able to balance your hormones because they can be customized, or personalized to levels that would be normal for you. In these circumstances, you may be asked to take a saliva test to estimate the amount of estrogen necessary to adjust your hormone levels. However, you should know that currently there is no scientific basis for using saliva testing to adjust hormone levels.
Saliva estrogen levels don’t reliably correspond to the hormone levels found in the bloodstream, and therefore don’t accurately reflect the amount of hormones present in your body. Instead, practitioners adjust hormone therapy dosages based on your symptoms, and the level of hormone needed to treat menopause symptoms can vary greatly from person to person and over time for each woman. Therefore, testing for a saliva level of estrogen doesn’t help adjust hormone therapy dosages, and the promotion of compounded menopause treatments using such saliva tests is very misleading. There are FDA-approved saliva tests for estrogen and progesterone, but these tests are not approved for use to measure hormone levels to adjust hormone therapy.
Bioidentical hormone therapy may improve symptoms of menopause for some women. If you choose to use BHT it’s important to be aware that evidence is lacking about its effectiveness in treating menopause. More importantly, safety information is frequently not available or provided when BHT is prescribed and dispensed by the compounding pharmacy. Until data become available, it’s safe to assume that the risks associated with the use of BHT are the same as for approved menopausal hormone therapies. Discuss your options with your healthcare provider, and if you decide to use either BHT or MHT, use the lowest dose that improves your symptoms for the shortest duration of time.
