Clinicians Should Avoid Prescribing Compounded Hormones
A new Scientific Statement issued on April 1st 2016 by the Endocrine Society in Boston advises clinicians to avoid using compounded hormone medications to treat menopausal symptoms, female sexual dysfunction, and other hormone conditions. The state was published in the Society’s Journal of Clinical Endocrinology & Metabolism.
According to a release from the society, these products — sometimes called bioidentical compounded hormones — are typically a mixture of hormones. Compounded hormone medications are prepared by licensed professionals or facilities specifically for an individual’s use. Compounded medications are meant to be an alternative when an individual does not have access to or has an adverse reaction to a medication approved by the U.S. Food & Drug Administration.
Compounded hormone medications can be unsafe when inappropriate practices are used. More than 60 people died from cases of fungal meningitis attributed to compounded medications in a 2010 case.
The release quotes Nanette Santoro, MD, the chair of the Society task force that developed the statement, as saying, “In extreme cases, advertisers have marketed compounded products as being able to prevent the ravages of aging and implied they are risk free. Few, if any, of these claims are supported by science.”
Widely available hormone treatments that are 100 percent chemically identical to the native hormones found in the body and that are approved by the U.S. Food & Drug Administration (FDA) offer effective and safe options for people with hormone disorders, and those approved treatments should be prescribed whenever possible, Santoro said.
Despite limited oversight of quality and dosage, bioidentical compounded hormones are used by millions of women to treat menopausal symptoms such as hot flashes and night sweats. Several market surveys indicate that custom-compounded menopausal hormone therapies earn $1 billion dollars in annual sales – enough to treat 2 million to 3 million women. The sales are equivalent to a quarter to a third of sales of menopausal hormone therapies approved by the U.S. Food & Drug Administration.
Although a large 2002 government study called the Women’s Health Initiative (WHI) raised concerns about menopausal hormone therapy raising the risks of blood clots, stroke, breast cancer and heart attacks in postmenopausal women, additional research conducted in the ensuing years has found that the level of risk depends on the individual woman’s health history, age and other factors. Experts have formed a consensus that the benefits of menopausal hormone therapy exceed the risks for most healthy women seeking relief from menopausal symptoms.