Concerns About Compounded Bioidentical Menopausal Hormone Therapy

Following the release of the Women's Health Initiative data, women began to use compounded bioidentical hormone therapy (cBHT) in the misguided belief of greater safety and efficacy than traditional hormone therapy. New guidelines recommend government-approved hormone therapy for symptomatic healthy menopausal women younger than 60 years or within 10 years of menopause at the time of initiation. For women requesting bioidentical hormones, those similar to the hormones present before menopause, there are many government-approved hormone therapies with extensive pharmacokinetic, safety, and efficacy data provided with package inserts delineating efficacy, safety, and potential risks. For women requesting non-Food and Drug Administration-approved (cBHT), these cBHTs lack data on pharmacokinetics, safety, and efficacy and are not provided a label detailing risk. Their use should be restricted to women with allergies or dosing or formulations not available in government-approved therapies. Pellet therapy providing women with supraphysiologic hormone dosing raises even more safety concerns.

Automated summary

Following the release of the Women's Health Initiative data, women began using compounded bioidentical hormone therapy (cBHT) believing it to be safer and more effective than traditional hormone therapy. New guidelines recommend government-approved hormone therapy for symptomatic healthy menopausal women under 60 years old or within 10 years of menopause. Government-approved hormone therapies similar to premenopausal hormones are available with extensive data on pharmacokinetics, safety, and efficacy. Non-Food and Drug Administration-approved cBHTs lack such data and should only be used for women with allergies or unavailable formulations. Pellet therapy with supraphysiologic hormone dosing raises safety concerns.