Be cautious when considering compounded hormones like estrogen as part of hormone therapy to help with menopause symptoms and hot flashes.

Women are cautioned against using compounded hormones (estrogen and progestin) to treat¹ the following:

• Menopausal symptoms (such as hot flashes)
• Sexual dysfunction or other conditions
• Other disorders

Major medical groups have warned against the use of these products.

Compounded hormones are made by special pharmacies called compounding pharmacies. They are marketed as being natural and safe. Celebrities have also promoted them. About one-third of American women who use hormone therapy take these compounded products².

Standard hormone therapy uses FDA-approved pharmaceutical-grade hormones. It largely fell out of favor in 2002 when a major study³ linked it to increased risk of breast cancer, heart attacks, and strokes in women mostly in their sixties. It is now mostly recommended for short-term use to prevent severe menopausal symptoms.

But some people continue to claim that supplemental custom-compounded hormones can not only treat menopausal symptoms (this is true) but also help keep women healthy and youthful (this is not true).

• There is the claim that compounded hormones are safe because they are the same as the ones women have in their bodies. But this is also misleading.
• There have been no large, long-term clinical trials on the effectiveness or safety of compounded hormones. The main concerns⁴ of experts are overdosing, underdosing, and contamination.
• Compounded hormones are not natural. They have undergone many processing steps in a lab without FDA oversight. Because of the lack of regulation, errors can occur.
• It is claimed that that the hormones are custom-compounded for the individual woman and are better than standard FDA-approved formulations. But chemical analyses show that compounded hormones usually are not the same as those produced in the body. They may also vary in potency and purity.
• The customization of this hormone therapy is questionable. To determine women’s hormone needs, practitioners often use alternative monitoring such as saliva testing. This is unreliable.

Bottom line

It’s hard to know how risky compounded hormones are. They can vary by dispenser and even from batch to batch. They are legal as long as they come from licensed pharmacists in response to valid prescriptions. But there is not much regulation or oversight. There is also no formal system for reporting bad side effects.

If they work like conventional hormone therapy, they carry the same risks but also may have added hazards of their own. Women should stay with FDA-approved hormones and follow the guidance on the labels and inserts.

 

References:

1. Endocrine Society, 2016.
2. North American Menopause Society
3. Women’s Health Initiative
4. Endocrine Society