There is also concern regarding bioidentical oral preparations, as there may be inconsistencies in the amounts of estradiol and other estrogen preparations in the composite preparations. This can increase the risk of venous thromboembolism, as well as the risk of endometrial cancer. According to the Food and Drug Administration (FDA) and several medical specialty groups, hormones that are marketed as bioidentical and natural are no safer than hormones used in traditional hormone therapy. There is also no evidence that they are more effective. More and more women who are candidates for hormone replacement therapy are asking for “bioidentical” hormones instead of synthetic hormones.
Although there is a tendency to think that bioidentical hormones are “totally natural”, like synthetic hormones, they are manufactured in the laboratory. Unlike synthetic hormones, they are chemically identical to the hormones produced by the human body; synthetic hormones are structurally different, but are designed to have biological effects similar to those of naturally produced hormones. In the media, women often receive the message that bioidentical hormones are safer and more effective; however, the bottom line is that we have no information to suggest that bioidentical hormones are safer or more advantageous for women than traditional hormonal treatments. All of these claims have been made by sellers of composite “bioidentical” hormones, also known as “bioidentical hormone replacement therapy”” (BHRT).
The FDA is concerned that statements such as these mislead women and health professionals, giving them a false sense of security about the use of potentially dangerous hormonal products. The FDA provides information about “BHRT” drugs and the uncertainties surrounding their safety and efficacy so that women and their doctors can make informed decisions about their use. During menopause, a woman's body produces less of the hormone estrogen, which can cause hot flashes, vaginal dryness, and thin bones. MHT medications contain estrogen or a combination of estrogen and another hormone, progestin.
FDA-approved MHT drugs are sold by prescription only, and the FDA advises women who choose to use hormones to use them at the lowest dose that helps them, for the shortest time needed. Some “BHRT” type drugs are sold in the form of compounds in pharmacies. The traditional composition consists of combining, mixing or modifying ingredients by a pharmacist, according to the prescription of a licensed health professional, to produce a medication that meets a person's special medical needs. The FDA considers traditional compounding to be a valuable service when used appropriately, such as personalizing a medication for a person who is allergic to a dye or preservative in a drug approved by the FDA.
However, some pharmacies containing drugs composed of “BHRT” unsubstantiated claim that these drugs are more effective and safer than FDA-approved MHT drugs. Drugs approved by the FDA must undergo a rigorous evaluation process by the agency, which analyzes everything related to the drug to ensure its safety and efficacy, from the first tests to the design and results of large clinical trials, the severity of side effects and the conditions under which they are manufactured. FDA-approved MHT drugs have undergone this process and have met all federal approval standards. No compound “BHRT” medication has met these standards.
The pharmacies that make up these “BHRT” drugs may not meet the good drug manufacturing requirements that apply to manufacturers of commercial drugs. Compound pharmacies mix these products to measure as directed by a healthcare professional. The mixture contains not only the active hormone, but also other inactive ingredients that help hold a pill together or give a cream, lotion or gel its shape and thickness so that it can be applied to the body. It is not known if these mixtures, which are not approved by the FDA, are properly absorbed or provide the adequate levels of hormones the body needs.
It is also unknown if the amount of drug administered is constant from one pill to another or each time a cream or gel is applied. In addition, the FDA has not approved any medications that contain the hormone estriol. Pharmacies should not combine medications containing estriol, unless the prescribing physician has a valid request for a new investigational drug (IND). INDs offer benefits that include allowing doctors to treat individual patients with drugs that are not approved by the FDA, while at the same time provide additional protective measures for patients.
If you are now taking a compound medication (BHRT), talk to your healthcare professional about treatment options to determine if composite medications are the best option for your particular medical needs. I guess I'll have to tell my sister to ask her doctor about treatment options because she's been taking bioidentical hormones for 5 years and believes that this is the safest way to replace hormones. You might be right to say that natural doesn't always mean safe, because all medications have side effects and the fact that they're not approved by the FDA may be the reason why adverse effects weren't reported. Thank you for such an informative post. Good information, would Premarin be considered a bioidentical hormone? Please explain it.
I too have had great relief from several ailments with BHRT and my provider has never told me that they are “safer than synthetic ones”. Simches Research Building 185 Cambridge St Suite 2200 Boston, MA 02114 Perinatal and Reproductive Psychiatry Program Keep up to date with the latest news about women's mental health and our research. Several FDA-approved hormone therapy products prescribed by doctors or other health care providers they contain bioidentical hormones. In fact, the hormones in bioidentical drugs may not be different from those in traditional hormone therapy.
In recent years, there has been an increase in the number of private clinics offering composite bioidentical hormone replacement therapy to women, which is a matter of great concern. Regulated bioidentical hormones are often referred to as “body identical hormones” (rBHRT) to reduce confusion with composite bioidentical hormones (cBHRT). Some of the hormones used in these bioidentical hormones contain hormones that are not approved for women, such as dehydroepiandrosterone (DHEA).) or pregnenolone. The term “bioidentical hormones” simply means that they have the same molecular structure as the body's hormones.
Compound bioidentical hormone replacement therapy does not contain the safety warnings for estrogen products found in all prescription hormone replacement preparations. Some women may benefit from atypical doses and forms of hormones in preparations composed of bioidentical hormones, but there is currently no scientific evidence to show that these compounds are more advantageous than commercially produced preparations. The term bioidentical means that the hormones in the product are chemically identical to that the body produces.
