The term, bioidentical, can mean different things to different people. For the majority of OB/GYN menopause specialists, it means hormones that are chemically identical to the hormones produced by the human body. For women, these are primarily produced in the ovaries during the reproductive years. As we know, a woman becomes “menopausal” when she transitions from a reproductive to a non-reproductive stage in her life. To learn more, please refer to my previous blog post, Why Menopause Happens.
A woman’s body produces various estrogens, such as 17-beta-estradiol, estrone, and estriol, as well as progesterone, testosterone and other hormones. Bioidentical hormone therapy can include any one or more of these hormones as the active ingredient and can come in the form of pills, creams, patches, gels, injectables and implants/pellets.
As we age, our ovaries can produce varying levels of these hormones and at menopause, defined as 12 consecutive months without a menstrual cycle, these hormonal levels decline precipitously. Many women due to their severe symptoms of hot flashes, night sweats, mood swings, vaginal dryness, etc. choose to go on bio-identical hormone therapy. I highly recommend that a woman seeks the advice of an experienced menopausal specialist to accurately review the pros and cons of BHRT for her own individual situation and medical/family history. Every woman is unique – and there is no “cookie-cutter” approach to hormone therapy.
FDA-approved Bio-identical Hormone Replacement Therapy (BHRT)
FDA-approved bio-identical hormone products are those that have been clinically studied for safety and efficacy, manufactured by a commercial pharmaceutical company and approved by the FDA. Interestingly, the FDA has stated that the term, BHRT, is a marketing term and not a term recognized by the FDA. These include such products, as well as many others:
Custom-Compounded Hormone Drugs
Compounding Pharmacies have been around for decades and have formulated various drugs for individual patients, allowing for tailored dosing and administration. These drugs can be in the forms noted above as well as in subdermal implants, sublingual tablets, rectal suppositories and nasal sprays. Many times, these products can be prepared without the fillers, dyes, binders or preservatives found in patented, commercially available products.
It is important to make the distinction that compounded hormone drugs do NOT go through the rigorous testing and quality control that determines the safety and efficacy required for FDA approval of commercially available hormones.
Since pharmacy compounding of custom medications is part of the routine practice of a pharmacy, regulation of these pharmacies is generally done by state medical or pharmacy boards and NOT by the federal government. Certain exceptions to this include those medications that are an exact copy to a commercially available drug product or those that pose a significant risk to patient safety or public health. Compounding Pharmacies have the option to be credentialed if they meet certain quality and safety standards through the Pharmacy Compounding Accreditation Board.
Lastly, it is important to note that there is NOT enough evidence to support the claim that compounded hormonal products are safer than commercially available products because double- blind, randomized, controlled studies have not been performed on them.
Importantly, choosing the right hormone therapy for a patient involves an in-depth discussion with a menopause specialist. In my practice, this visit usually takes about 45 – 60 minutes and includes the pros and cons of hormone therapy, which type, dose and administration as well as a review of medical and family history.