Twenty-eight to 68% of women using hormone therapy for menopausal symptoms are using compounded hormones. Many, however, are not aware that these treatments have not been evaluated or approved by the FDA, according to results from two surveys published in Menopause.
Because prescriptions of compounded hormones, also known as bioidentical hormones, are not tracked in the same way as FDA-approved drugs are, the researchers used two large Internet surveys — the Harris and Rose surveys —to gauge how often women used approved hormone therapy or compounded hormone therapy at menopause.
The Harris survey included 801 women aged 45 to 60 years who had experienced at least one menopausal symptom. The Rose survey was administered to 2,044 women aged at least 40 years who were ever users of hormone therapy. Women were asked about menopausal symptoms, hormone therapy use and knowledge of compounded hormone therapy.
The researchers also extrapolated findings from the Rose survey using U.S. Census Bureau data as well as prescription claims for FDA-approved hormone therapy to estimate the prevalence of compounded hormone therapy use.
Extrapolations from the Rose survey indicated that up to 2.5 million U.S. women aged at least 40 years may use compounded hormone therapy per year. This number accounts for 28% to 68% of hormone therapy prescriptions, according to the data.
Findings from the Harris study also demonstrated that 86% of women were not aware that compounded hormone therapy products are not approved by the FDA.
The Rose survey also polled a subset of 1,771 women about whether their hormone therapy had been personalized based on their hormone levels. Results showed that 21% responded “yes,” while 27% said they did not know.
Findings from both surveys suggested that most women using hormone therapy said the treatment was recommended by a physician.
“Our data support the general consensus that the [compounded hormone therapy] market is growing. Conversely, the market for FDA-approved [hormone therapy] shrank dramatically in the past decade or so,” the researchers wrote.
They also speculated as to why compounded hormones have grown in popularity.
“Some may choose [compounded hormone therapy] over FDA-approved [hormone therapy] because of Internet-perpetrated myths that compounded hormones are more natural and thus safer than commercially manufactured ones,” they wrote.
Nevertheless, the researchers noted, many women are unaware of the potential risks and benefits. Further, compounding pharmacies are not required to label compounded hormone therapy or provide detailed prescribing information, which may contribute to women’s lack of knowledge about these products.
Because the study results show that women often seek information from their physicians about hormone therapy use for menopausal symptoms, health care providers can play an important role in educating patients, according to the researchers.
“Providers can play a pivotal role in helping women understand the different levels of evidence supporting the efficacy, safety, and quality of [compounded hormone therapy] versus FDA-approved [hormone therapy] and the differences in FDA regulation and monitoring between compounded and approved drugs,” the researchers wrote.
Margery L. Gass, MD, executive director of the North American Menopause Society, commented on the findings.
“These results indicate a general lack of understanding about key differences between compounded and FDA-approved hormone therapy. This publication establishes the need for better education on this topic,” Dr. Gass said.