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.
“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:
Myth: “Bio-identical” hormones are safer and more effective than FDA-approved MHT drugs.
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.
Drugs that are approved by 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. FDA-approved MHT drugs have undergone this process and met all federal standards for approval. No compounded “BHRT” drug has met these standards.
Pharmacies that compound these “BHRT” drugs may not follow good drug manufacturing requirements that apply to commercial drug manufacturers. Compounding pharmacies custom-mix these products according to a healthcare professional’s order. The mix contains not only the active hormone, but 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. It is unknown whether these mixtures, which are not FDA-approved, are properly absorbed or provide the appropriate levels of hormones needed in the body. It is also unknown whether the amount of drug delivered is consistent from pill to pill or each time a cream or gel is applied.
Myth: “Bio-identical” hormone products can prevent or cure heart disease, Alzheimer’s disease, and breast cancer.
Fact: Compounded “BHRT” drugs have not been shown to prevent or cure any of these diseases. In fact, like FDA-approved MHT drugs, they may increase the risk of heart disease, breast cancer, and dementia in some women. (Seewww.nhlbi.nih.gov/whi/ for information on the Women’s Health Initiative, a large, long-term study that tested the effects of FDA-approved MHT drugs.) No large, long-term study has been done to determine the adverse effects of “bio-identical” hormones.
Myth: “Bio-identical” hormone products that contain estriol, a weak form of estrogen, are safer than FDA-approved estrogen products.
Fact: FDA has not approved any drug containing estriol. The safety and effectiveness of estriol are unknown. “No data have been submitted to FDA that demonstrate that estriol is safe and effective,” according to Daniel Shames, M.D., a senior official in the FDA office that oversees reproductive products.
Myth: If “bio-identical” products were unsafe, there would be a lot of reports of bad side effects.
Fact: “Bio-identical” products are typically compounded in pharmacies. “Unlike commercial drug manufacturers, pharmacies aren’t required to report adverse events associated with compounded drugs,” says Steve Silverman, Assistant Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “Also, while some health risks associated with ‘BHRT’ drugs may arise after a relatively short period of use, others may not occur for many years. One of the big problems is that we just don’t know what risks are associated with these so-called ‘bio-identicals.’”
Myth: A pharmacy can make a “BHRT” drug just for you based on hormone levels in a saliva sample.
Fact: “Advertisements that a drug can be created ‘just for you’ based on saliva testing are appealing,” says Uhl, “but unrealistic.” Hormone levels in saliva do not accurately reflect the amount of hormones a woman has in her body for the purpose of adjusting hormone therapy dose levels. A woman’s hormone levels change throughout the day, and from day to day. FDA-approved tests can tell a woman’s hormone level in a specific body fluid, such as saliva, blood, or urine, at that particular point in time. “These tests are useful to tell if a woman is menopausal or not,” says Uhl, “but they have not been shown to be useful for adjusting hormone therapy dosages.”
Myth: FDA wants all compounded hormone therapies off the market.
Fact: “We are not trying to pull all compounded hormone therapies off the market,” says Silverman. “We believe that, like all traditionally compounded drugs, a woman should be able to get a compounded hormone therapy drug when her physician decides that it will best serve her specific medical needs. But we also want women to be informed and careful about choosing products that have not been proven safe and effective. And pharmacies cannot promote compounded drugs with false or misleading claims.” In addition, FDA has not approved any drug containing the hormone estriol. Pharmacies should not compound drugs containing estriol unless the prescriber has a valid investigational new drug (IND) application. INDs provide benefits that include allowing physicians to treat individual patients with drugs that are not FDA-approved, while also providing additional safeguards for patients.
Myth: All women who take FDA-approved MHT drugs are going to get blood clots, heart attacks, strokes, breast cancer, or gallbladder disease.
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
Bioidentical Hormone Therapy (North American Menopause Society)
Compounded Bioidentical Menopausal Hormone Therapy (American College of Obstetricians and Gynecologists)