FEATURED ISSUE
Possible threat to compounded bioidentical hormones?
Bioidentical hormones have been nominated to be addedto the Food and Drug Administration’s Demonstrably Difficult to Compound List. When something is officially addedto this FDA list, that item will no longer be allowed to be made at compounding pharmacies. Note that there are synthetic and natural hormone product options. Both have been approved as safe and effective by the FDA. However, many individuals are not able to assimilate synthetic hormones and need a customized dosage level of the natural bioidentical hormone option. And this latter is only available through a compounding pharmacy.

The issue appears to be that because the FDA has not tested and approved the customized compoundedforms, there must be the possibility that they are not safe or effective. The fate of compounded bioidentical hormones appears to have been turned over by the FDA to the Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”study committee of the National Academies of Science, Engineering, and Medicine. This month is the sixth meeting in a series that has taken place throughout 2019. Reviewing the actions taken so far by this committee has raised some concerns about a possible preexisting bias among committee members towards supporting the position that compounded bioidentical hormones are neither safe nor effective.

This matter might not be so serious, if there were an alternative for those who cannot assimilate the synthetic hormones and require a controlled compounded dosage level of the natural bioidentical hormone option. What will these individuals (mostly women) do if their only source is banned?

ISSUE: Safety and effectiveness of compounded bioidentical hormones

AHHA strives to maintain a neutral position on issues and viewsknowledge as power. For those interested in this month’s issue and learning more about this topic the articles below were selected to offer you some resources to begin your research.

PRO
The Benefits of Compounded Hormones Can Enhance Menopause and Andropause Treatment (8/13/19)
BodyLogicMD

FDA Rigs Process Against Estriol, Other Bioidenticals (11/7/19)
Alliance for Natural Health

Uses and Benefits of Compounded Progesterone (4/26/19)
Harbor Compounding Pharmacy

CON
Compounded Bioidentical Hormone Therapy (10/2/19)
Endocrine Society

HRT Has an Uncertainty Problem. Does Compounding Make It Worse? (2/13/19)
Managed Care

Bioidentical Hormones
Cleveland Clinic

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