More than one-third of women who take hormones at menopause are using compounded hormones, despite a lack of previous testing for these drugs, according to results of a survey.
These data were presented at the North American Menopause Society (NAMS) 2015 Annual Meeting and simultaneously published in the journal Menopause.
“Compounded hormones are mixtures that have never been tested, researched, or submitted to the FDA for consideration for approval as a new drug,” Wulf H. Utian, MD, PhD, DSc, executive director of NAMS and study investigator, told Endocrinology Advisor. “And what women think they are getting is not exactly what is on the label, so they may be exposed to extra risk.”
To better understand this risk and the extent of compounded hormone use, Dr Utian and colleagues sent out a survey to women that assessed several factors, including hormone use at menopause, the expected and observed benefits, and the side effects. In all, 3,700 women aged 40 to 84 years took part in the survey.
Results indicated that approximately 1,000 respondents had used or were taking hormone therapy at menopause. Among those receiving hormone therapy, 31% were taking or had taken compounded hormones, whereas 34% were taking them at the time of the survey.
Furthermore, 42% of those who took compounded hormones believed that “natural” or “bioidentical” hormones are safer than other types of hormones.
“People believed that because [compounded hormones] were ‘natural’ and ‘bioidentical’ they never carried any of the risks that were being ascribed to the FDA-approved products,” Dr Utian said.
“This has been looked at many different ways over the years and the FDA itself has said that the word ‘bioidentical’ is not a scientific term, but rather a marketing term, which all of us agree that it is. The Endocrine Society, NAMS, and the American Congress of [Obstetricians and Gynecologists] have each come out with position statements saying that women should be careful about taking compounded products, which may cause harm, or certainly, at the very least, carry the same risks as any FDA-approved product.”
One of the concerns Dr Utian mentioned is a potential link between use of compounded hormones and uterine cancer. He said that in recent years, there have been reports — one from Australia and another from New York — of between two to three cases of uterine cancer each in women on compounded products.
In the current study, Dr Utian and colleagues found that four women taking the compounded products reported having uterine cancer compared with no women who were taking the FDA-approved products.
“We’re not saying that we have proven use of compounded products is causing uterine cancer, but there is enough information now to cast a very wary eye over what is going on, and to scrutinize these products much more closely,” Dr Utian said. “These are extremely difficult products to compound, which is why they need to be done in FDA-scrutinized facilities.”
Going forward, Dr Utian recommends that endocrinologists stop prescribing compounded hormones because the components are available in FDA-approved products.
“Also, if [endocrinologists] go the compounded route and something does go wrong, they are exposed legally, because virtually all of their own societies have come out with position statements warning them against doing exactly that,” he said.
- Utian WH, et al. Presented at: North American Menopause Society (NAMS) 2015 Annual Meeting; Sept. 30-Oct. 3, 2015; Las Vegas.