According to data presented at the annual meeting of the North American Menopause Society (NAMS)  in Las Vega, a growing number of perimenopausal women are asking their doctors for compounded or bioidentical hormones.  Although bioidentical hormones are touted as being “natural”, they, like synthetic hormones, are manufactured in the laboratory.   Bioidentical hormones are chemically identical to the hormones produced by the human body, whereas synthetic hormones are structurally different yet are designed to have similar biological effects as the naturally produced hormones.

An Internet survey of 3,725 peri- and postmenopausal women aged 40 to 84 years indicated that about 9% of women were using hormonal therapy, most commonly to manage vasomotor symptoms.  About one-third of those women were using compounded hormone preparations.  Compounded hormones were believed to be safer than FDA-approved hormone therapy by 42% of compounded hormone users and by 25% of FDA-approved hormone users.

In the media, women are often given the message that bioidentical hormones are safer and more effective than traditional hormone therapy.  Countering the claims of the makers of bioidentical hormones, NAMS and other medical organizations have cautioned against the use of bioidentical hormones: “Little or no scientific or medical evidence supports claims that bioidentical hormones are safer or more effective than more traditional FDA-approved therapies. In addition, many custom-compounded “bioidentical hormone” formulations are not subject to FDA oversight and can be inconsistent in dose and purity.”  Despite the lack of evidence to support the use of bioidentical hormones, many physicians feel pressured to prescribe what their patients demand.  

But without FDA oversight and regulation, there is no guarantee that these custom-made compounded preparations contain active ingredients that are absorbed appropriately or that they provide predictable therapeutic levels.   Perhaps one of the most concerning findings was that many compounding pharmacies produce a product that has supertherapeutic levels of estrogens and subtherapeutic levels of progestins, a combination that could increase the risk of endometrial hyperplasia and cancer.  

An excellent review posted on the US FDA site addresses some of the myths surrounding bioidentical hormones:

“BHRT” is a marketing term not recognized by FDA. Sellers of compounded “bio-identical” hormones often claim that their products are identical to hormones made by the body and that these “all-natural” pills, creams, lotions, and gels are without the risks of drugs approved by FDA for menopausal hormone therapy (MHT). FDA-approved MHT drugs provide effective relief of the symptoms of menopause such as hot flashes and vaginal dryness. They also can prevent thinning of bones. FDA has not approved compounded “BHRT” drugs and cannot assure their safety or effectiveness.

Some “BHRT” drugs are compounded in pharmacies. Traditional compounding involves combining, mixing, or altering ingredients by a pharmacist, according to a prescription from a licensed health care professional, to produce a drug that meets an individual’s special medical needs. FDA considers traditional compounding to be a valuable service when used appropriately, such as customizing a drug for someone who is allergic to a dye or preservative in an FDA-approved medicine. But some pharmacies that compound “BHRT” drugs make unsupported claims that these drugs are more effective and safer than FDA-approved MHT drugs.

FDA is taking action against pharmacies that make false and misleading claims about “BHRT” drugs and is encouraging consumers to become informed about these products and their risks. Here is some information to help sort the myths from the facts:


Fact: FDA is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded “BHRT” drugs. “They are not safer just because they are ‘natural,’” says Kathleen Uhl, M.D., Director of FDA’s Office of Women’s Health.









Myth: A pharmacy can make a “BHRT” drug just for you based on hormone levels in a saliva sample.


Myth: FDA wants all compounded hormone therapies off the market.



Fact: Like all medicines, hormone therapy has risks and benefits. For some women, hormone therapy may increase their chances of getting these conditions. However, there are no convincing data that there is less risk of developing a blood clot, heart attack, stroke, breast cancer, or gallbladder disease with a “BHRT” product. Women should talk to their health care professional about taking hormones. If you decide to use MHT drugs for menopause

  • use at the lowest dose that is beneficial
  • use for the shortest time needed

If you are taking a compounded “BHRT” drug now, talk to your health care professional about treatment options to determine if compounded drugs are the best option for your particular medical needs.

Marlene P. Freeman, MD

Ruta Nonacs, MD PhD

Women Are Demanding, and Receiving, Compounded Hormones (Medscape)

Bioidentical Hormone Therapy (North American Menopause Society)

Compounded Bioidentical Menopausal Hormone Therapy (American College of Obstetricians and Gynecologists)