Compounded Hormone Medication Prescriptions Raise Concerns

Compounded hormone medications linked with potential risks and side effects.

Due to some potential risks from compounded hormone medications, the Endocrine Society is advising clinicians to avoid prescribing these drugs to patients with menopausal symptoms, female sexual dysfunction, and other hormonal conditions.

These medications are meant to act as an alternative for patients without access or who have an adverse reaction to drugs for these conditions. However, these medications can cause harm to individuals when inappropriate practices are used.

In 2010, more than 60 people died from fungal meningitis attributed to compounded hormonal medications.

“In extreme cases, advertisers have marketed compounded products as being able to prevent the ravages of aging and implied they are risk free,” said researcher Nanette Santoro, MD. “Few, if any, of these claims are supported by science.”

However, Santoro states that FDA-approved hormone treatments that are 100% identical to the native hormones in the body are a safe and effective option for patients with hormone disorders.

In 2002, the Women’s Health Initiative (WHI) raised concerns regarding menopausal hormonal therapy that may increase the risk of blood clots, stroke, breast cancer, and heart attacks in postmenopausal women.

However, further research found that the level of risk is dependent upon individual factors, such as health history or age. Experts formed a consensus that the benefits of menopausal hormone therapy exceeds the health risks in healthy women.

At the time, there was a misconception that FDA-approved treatments were unsafe, causing some women to use a custom-compounded menopausal hormone therapy (MHT).

However, there have been no large scale, long-term studies done to test the safety and effiacy of custom compounded MHT. Researchers said there is no scientific or medical reason to use a custom MHT, which has an unknown effect on the body, when there are several FDA-approved menopausal treatments available to choose from.

While examining compounded hormone treatments that boost testosterone levels in women with sexual dysfunction, there were no scientific studies that support the use of dehydroepiandrosterone.

Additionally, compounded medications can also be used to treat thyroid disorders, but FDA-approved thyroid medications remain the treatment of choice because of safety and efficacy.

Some patients could benefit from compounded thyroid medications or desiccated thyroid hormone, which is extracted from animals, but should have their Thyroid-Stimulating Hormone (TSH) levels and symptoms continually monitored.

Although new regulations being developed by the FDA could lead to an improvement in safety and quality control for compounded medications, they should still be used in limited situations at this time due to concerns for the risks of under-dosing, overdosing, or contamination.

“Custom-compounded hormones should be reserved for situations in which a patient is allergic to or does not tolerate any of the FDA-approved therapies, and treatment is necessary for his or her health,” Santoro said.