BALTIMORE — The off-label prescribing of compounded, bioidentical hormone therapy — in pills, creams, or pellets — for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the 2023 annual meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the US Food and Drug Administration (FDA).

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center School of Medicine in Amarillo.

Dr Robert Kauffman

Following the 2002 Women’s Health Initiative report showing a link between hormone replacement therapy (HRT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Kauffman said. The association was later determined to be spurious: HRT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HRT still is largely ignored by younger physicians, Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.

The lack of education on HRT for medical school students and residents has “opened the door to unsubstantiated marketing claims and practices” for cBHT, Kauffman said. “Hence, the use of compounded bioidentical hormone therapy has increased” as clinicians look for alternatives.

Groups including ACOG, the North American Menopause Society (NAMS), and the US Preventive Services Task Force recommend against the use of Non–fda-approved therapies like cBHT, except for narrow indications. Kauffman said that drug manufacturers have not conducted randomized controlled trials or observational studies on cBHT in treating menopause.

Kauffman cited studies showing quality problems with the compounding process of these drugs, and wide variations in the amount of actual ingredients from product labels. One 2021 study published in Menopause comparing patients taking cBHT or FDA-approved HRT found that side effects were significantly higher in the cBHT group (57.6% vs 14.8%; P < .0001).

But manufacturers of cBHT claim that their products prevent cardiovascular disease and Alzheimer’s disease and decrease the risk for breast cancer and stroke — assertions that are at best unproven, according to Kauffman.

The National Academies of Sciences, Engineering, and Medicine in 2020 said that clinicians have a duty to inform patients of the insufficient evidence to support clinical use of cBHT and should prescribe the products only to patients with documented allergies to an active ingredient in an FDA-approved agent or who require an alternative dosage.

Patients may also have to pay much more out of pocket for cBHT products because they often are not covered by insurance. Generic HRT products, meanwhile, are relatively inexpensive and typically are covered, he noted.

“We have to be careful to avoid financial harm to patients by prescribing things which are much more expensive than those which are usually available,” Kauffman said.

Prescribing any non–FDA-approved product, especially when biosimilars are available, places physicians at legal risk, Kauffman said. Physicians who recommend cBHT should inform patients that the products are not FDA-approved and carefully document this discussion in the patient’s electronic health record. State boards of medicine can sanction physicians for “coercion” for prescribing cBHT products without mentioning alternatives, he added.

JoAnn Pinkerton, MD, professor of obstetrics and gynecology at the University of Virginia, in Charlottesville, and Executive Director Emeritus of NAMS, who attended the session, praised Kauffman for providing a balanced and evidence-based overview of the subject.

“There are issues concerning safety, contaminants, and not knowing exactly what dose you’re getting,” with compounded hormones, Pinkerton said. “They’re being hyped as safer and more effective when in reality, we don’t have any studies that show that information.”

Pinkerton noted that while a compounded form of physiological testosterone might be relatively reliable, “if you’re using something like a pellet that is super physiologic with incredibly high doses, that you really don’t have any information to stand on that it’s safe or effective… it might be putting your license at risk.”

American College of Obstetricians and Gynecologists (ACOG) 2023 Annual Meeting. Presented May 20.

Kauffman and Pinkerton report no relevant financial relationships.

Karen Blum is a freelance medical/science writer in the Baltimore area.

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