Custom-compounded hormones linked to risks, side effects in menopausal women

BOSTON — Clinicians should avoid prescribing custom-compounded bioidentical hormones for the treatment of menopausal symptoms due to the potential risks and side effects the unregulated drugs carry, according to a new scientific statement issued by the Endocrine Society here.

The society encouraged clinicians to prescribe FDA-approved hormone products and recommended that custom-compounded hormones be limited to rare cases in which the patient is either allergic to FDA-approved preparations or cannot tolerate FDA-approved drugs.

“By no means do I wish to disparage the practice of pharmacists who are measuring hormones and providing them to patients,” Nanette Santoro, MD, professor and chair of reproductive endocrinology and infertility, department of obstetrics and gynecology at the University of Colorado Denver, said during a press conference discussing the recommendations. “Where we get into scientific trouble ... is as soon as something is being custom compounded, it’s being measured out and added to a variety of agents and diluters that will make it into a pill or a gel. ... How these excipients influence how these hormones get into a person, and what that hormone does, is essentially unknown.”

Nanette Santoro

In recent surveys, Santoro said, researchers found that between one-quarter and one-third of prescriptions for menopausal hormone therapy are custom-compounded hormones, despite limited oversight regarding drug quality and dosage. Santoro cited evidence in 2014 of deaths resulting from custom-compounded glucocorticoid therapy from a pharmacy that was improperly regulated and not adhering to manufacturing practices.

“This, to us, seems somewhat absurd when we have a large variety of what are, technically, the same bioidentical hormones that are FDA approved,” Santoro said. “It is also a perversion of the intent of the practice of custom compounding. Every doctor relies on a pharmacist to provide a custom-compounded product when their patient is intolerant, allergic or cannot take what is FDA approved.”

These current numbers “were never the intent of compounding,” she said. In addition, no large-scale, long-term studies have been conducted to examine the safety and effectiveness of custom-compounded menopausal hormone therapy. Misconceptions that custom-compounded hormone therapy is safer, more efficacious and less likely to cause cancers than FDA-approved therapies are unfounded, Santoro said.

The statement also examined compounded hormone treatments used to boost testosterone levels for women who experience sexual dysfunction. Currently, there are no FDA-approved testosterone or dehydroepiandrosterone therapies for women, and scientific studies indicate the treatments are not effective, according to the statement. Concerns remain about under- or overdosing, as well as side effects from these treatments.

“What has happened is the absence of evidence of harm is taken as proof of safety,” Santoro said. “This is very illogical, yet it pervades the media and the popular press. You see happy people with anecdotes ... what we don’t know is how much they’re getting and what are the biological endpoints?”

Researchers also recommended FDA-approved synthetic thyroid medications to treat thyroid disorders, recognizing that some patients may benefit from compounded thyroid medications or desiccated thyroid hormone extracted from animals. Patients using these alternative treatments should have their thyroid-stimulating hormone levels monitored carefully, researchers said.

The Scientific Statement was published online in The Journal of Clinical Endocrinology & Metabolism. – by Regina Schaffer

Reference:

Santoro N, et al. Compounded bioidentical hormones in endocrinology practice: An Endocrine Society Scientific Statement. Presented at: The Endocrine Society Annual Meeting; April 1-4, 2016; Boston.

Disclosure: Santoro reports receiving grant support from Bayer Inc. and stock options from MenoGeniX. Please see the full scientific statement for the other authors’ relevant financial disclosures.