Endocrine Society Recommends Against Routine Use of Compounded Hormones

Bioidentical hormones are identical in structure to those produced naturally in the human body. They are used to treat various hormone-related conditions, such as menopausal symptoms (hot flashes, night sweats and vaginal dryness) and hypothyroidism (underactive thyroid), and come in various forms, including pills, patches, sprays, creams and injections.

Some of these products are manufactured by drug companies in monitored facilities, are sold in standard doses and have been approved by the Food and Drug Administration (FDA). Others are custom-mixed (compounded) in special pharmacies called compounding pharmacies. Compounded hormones come in dosages that purportedly are tailored to individual patients. However, they are not tested for dosage accuracy, safety or effectiveness, nor are they reviewed or approved by the FDA.

The Endocrine Society, an organization of endocrinologists and endocrine researchers, issued a statement in the April 2016 issue of The Journal of Clinical Endocrinology and Metabolism about compounded hormones.[1] It recommended that clinicians refrain from prescribing these products routinely to patients because they are unregulated and potentially ineffective and harmful.

The statement is the latest in a series from medical societies — including the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine and the North American Menopause Society — that recommend against the use of compounded hormone products over approved products.

Increased use

The use of compounded hormones has grown dramatically in recent years. For example, survey studies showed that up to 31 percent of American women who reported ever having used menopausal hormone therapy took compounded products.[2]

The surge in use of compounded hormones is largely due to the following factors:[3]

• Most patients are not aware that these products are not approved and are ill informed about their risks.
• There is little regulation governing the advertising of these products, which allows purveyors to make unsubstantiated claims about their effectiveness and safety.
• These products are often promoted by high-profile celebrities and even some health care practitioners who stand to benefit economically from the sale of these products.

Lack of oversight

States oversee the certification and licensing of compounding pharmacies that make compounded hormones. These facilities are not required to register with the FDA and are not held to the same rigorous standards as manufacturers of approved products with respect to ensuring the quality of their products. Instead, the FDA inspects them only in case of complaints.

Further, the makers of compounded hormones are not required to label their products or include important safety warnings on the labels. They are also not required to report adverse events associated with their products.

No supportive evidence

The Endocrine Society’s statement emphasized the lack of large, longterm and appropriately designed clinical trials to support the effectiveness and safety of compounded hormone products.

The society cautioned that compounded estrogen and progestin hormones, used to ease menopausal symptoms, carry the same risks of potentially causing endometrial and breast cancers, strokes, heart attacks, and serious blood clots as do FDA approved hormone drugs. It noted that there is no evidence to support the use of salivary or blood testing to monitor hormone levels, which is commonly requested by compounded hormone prescribers.

The statement recommended the use of approved testosterone hormone products over compounded products in men with hypogonadism (little or no male sex hormones). However, it stressed that no testosterone products should be used in women, who may be prescribed these products — inappropriately — to overcome sexual dysfunction. It clarified that the FDA has not approved any testosterone products for women and that compounded forms can be particularly harmful due to potential overdosing.

For thyroid hormones, the statement asserted that levothyroxine (LEVO-T, LEVOXYL, SYNTHROID, TIROSINT, UNITHROID) is a highly effective and safe therapy for hypothyroidism, eliminating the need for compounded thyroid hormone products from synthetic or animal sources. Although the statement permitted compounded hormones, such as desiccated thyroid extracts, for the small subset of patients with persistent hypothyroid symptoms despite treatment with levothyroxine, we have long recommended against using these products altogether. See the November issue of Worst Pills, Best Pills News or WorstPills.org for more detail about our recommendations regarding the oral treatments for hypothyroidism.[4]

Risks of compounding

The statement also highlighted that compounded hormones are produced and administered without adequate standardization or quality control, leading to the possibility of overdosing or underdosing. Additionally, these products can be subject to contamination, with deadly consequences. For example, more than 60 people died from funguscontaminated compounded steroid injections administered in 2012.[5],[6]

While some of the risks associated with compounded hormones may arise after a relatively short time, others may not manifest for many years.[7] We simply do not know the long-term risks associated with these products.

Recommendations

Due to the widespread availability of approved and effective bioidentical hormones produced in facilities monitored for safety, the statement concluded, there is no rationale for the routine use of compounded hormone products.

The statement advised that until new regulations are implemented to improve safety and quality control, compounded hormones should be used only in limited situations, such as when patients are allergic to or do not tolerate approved products.

What You Can Do

Whenever a commercially available, approved brand-name or generic version of a hormone, or any other drug, made by a pharmaceutical company is available, you should always choose it over any product made by a compounding pharmacy. This is particularly true for injectable products because they carry increased risk of life-threatening complications in case of contamination or preparation errors.

You should only use compounded products for situations in which you have an allergic reaction to, or cannot tolerate, any of the approved products that are necessary for your condition.

You should be skeptical of health care providers who promote compounded drugs for routine use. If a health care professional tells you that the only treatment for your condition is a compounded drug, get a second opinion.

Even approved prescription estrogen products used to ease the natural transition into menopause should be used at the lowest effective dose and for the shortest duration consistent with treatment goals.[8] This is because estrogen products increase the risk of cardiovascular disease, breast cancer and dementia.

Women should avoid testosterone products. Public Citizen’s Health Research Group recommends approved testosterone products only for men with confirmed hypogonadism, because testosterone therapy has been linked to an increased risk of heart attacks and strokes.[9]

You should not discontinue the use of any medication without first consulting your doctor.

References

[1] Santoro N, Braunstein GD, Butts CL, et al. Compounded bioidentical hormones in endocrinology practice: An Endocrine Society scientific statement. J Clin Endocrinol Metab. 2016;101(4):1318-1343.

[2] Gass MLS, Stuenkel CA, Utian WH, et al. Use of compounded hormone therapy in the United States: Report of The North American Menopause Society Survey. Menopause. 2015;22(12):1276-1284.

[3] Pinkerton JV, Santoro N. Compounded bioidentical menopausal hormone therapy. Fertil Steril. 2012;98(2):308-312.

[4] Oral treatment for hypothyroidism. Worst Pills, Best Pills News. November 2016. /newsletters/view/1067. Accessed November 7, 2016.

[5] Smith RM, Schaefer MK, Kainer MA, et al. Fungal infections associated with contaminated methylprednisolone injections. N Engl J Med. 2013;369(17):1598-1609.

[6] Fungal meningitis outbreak highlights the dangers of compounding pharmacies. Health Letter. December 2012. http://www.citizen.org/documents/HL_201212.pdf. Accessed September 14, 2016.

[7] Food and Drug Administration Consumer Health Information. Bio-identicals: Sorting myths from facts. April 8, 2008. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm. Accessed September 14, 2016.

[8] Beware: Bioidentical hormones. Worst Pills, Best Pills News. September 2010. /newsletters/view/710. Accessed September 14, 2016.

[9] Testosterone use linked to increased risk of heart attacks. Worst Pills, Best Pills News. March 2014. /newsletters/view/891. Accessed September 14, 2016.