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NAMS: Physicians should warn against compounded hormones’ ‘false claims’

One-third of women who take hormones at menopause are using non-FDA-approved compounded drugs, according to a national survey recently published in Menopause, the journal of the North American Menopause Society.

The survey, which polled 3,700 women aged 40 to 84 about their hormone use during menopause, found that, of the 1,000 who had used hormone therapy, 31% were taking or had taken compounded hormones, and 34% were taking them at the time of the survey.

“In many ways, what the survey has done is confirm a number of impressions, and some substantiated data that has already appeared in press,” NAMS Executive Director Wulf H. Utian, MD, PhD, DSc, told Endocrine Today.

Utian, who presented the survey findings at the NAMS Annual Meeting on Oct. 3, said the use of compounded hormones represents a growing — and worrying — trend that began more than a decade ago. Estimating that compounded drugs represent a $1.5 to $3 billion market in the U.S., he added that they lack the scrutiny placed on FDA-approved products.

“What happened was that a number of physicians, many of them describing themselves as anti-aging doctors, decided they wanted to prescribe hormones, but that they would come up with terminology, using words like ‘bioidentical’ and ‘natural,’ and the claims — false claims — that these were safer and didn’t carry the risks of the FDA-approved products,” Utian said. “Clearly that was wrong, but what has been difficult over the last 12 to 13 years is to actually calculate the size of compounded hormone therapy market.”

The reason for that difficulty, according to Utian, is that, unlike FDA-approved products, compounded hormone prescriptions do not have to be reported and often do no end up in any researchable databases.

“Only way to get information is to go directly to the women,” Utian said.

Going directly to the women, the team found that 42% of the women who took compounded hormones thought natural or bioidentical hormones were safer than other types of hormones.

In addition, while side effects of hormone therapy were uncommon throughout the survey respondents, the women who used compounded drugs reported higher rates of vaginal bleeding and acne, compared with those who used FDA-approved hormones.

Four of the women who used compounded hormones reported they had endometrial cancer, while no such diagnosis was reported among those who took FDA-approved drugs.

“Now, none of that actually is absolute proof, but it’s what I call the canary in the coal mine,” Utian told Endocrine Today. “It’s warning us that there’s maybe a problem about to land in all our laps.”

Utian said physicians should be more proactive in talking to patients about the differences between compounded hormones and those approved by the FDA, which are subject to good manufacturing practices, and to having a proven and tested active pharmaceutical ingredient.

According to Utian, compounded drugs are under no such scrutiny.

“Virtually every organization that has some association with women’s health care has cautioned clinicians against the use of compounded, so-called bioidentical hormones, and advised clinicians to only prescribe FDA-approved products, and to explain to their patients that there’s a problem,” Utian said.

There is also a risk to clinicians, he added, as such organizations are unlikely to stand behind them if something goes wrong with a compounded drug they have prescribed.

Most of the women surveyed who used either compounded or FDA-approved hormones — about 70% of each group — took them for hot flashes. However, those who took compounded hormones more often expected other, unproven benefits, such as relieving irritability, or to improve sleep, energy level, depression, muscle mass, memory, sexual desire and overall appearance, as well to prevent aging and to lose weight.

In addition, Utian noted the survey found that whether or not a patient takes compounded or FDA-approved hormones depended largely on what kind of physician made the prescription.

“When they tended to see OBGYNs or regular internists, there was a greater tendency for FDA-approved products,” Utian told Endocrine Today. “When they went to anti-aging doctors — they are described as ‘anti-aging specialists’ — they were very likely to get a compounded product.”

Utian is currently advocating that the term “bioidentical” be eliminated from the medical lexicon, calling it “offensive,” and a claim that is “completely unsubstantiated.”

“It just misleads women and makes them think that they’re getting something which they’re not,” Utian said. “I would just caution that in the best interest of their patients and themselves, and the patients’ pocketbooks, physicians should prescribe FDA-approved products, because the so-called ‘natural’ estradiol [and] progesterone are available in a multiplicity of FDA-approved products.” — by Jason Laday