FDA-approved bioidentical estrogens help women manage common symptoms of menopause

Jul 8 2010

Women looking for the best method to manage common symptoms of menopause, like hot flashes and night sweats, may not have access to credible information, especially when it comes to understanding their estrogen therapy options.  In fact, there are an array of celebrities and authors who are simply not qualified to give medical advice about managing menopause, yet they dominate the internet and media space simply because of their popularity.  Many medical experts believe that the influence of these non-medical professionals has been an obstacle to women learning about the newer generation of bioidentical estrogens that are FDA-approved.  

"It is important that women understand what bioidentical hormones are and the differences between those that are FDA-approved and those that are compounded or "mixed" at the pharmacy level," said Dr. Ricki Pollycove, M.D.M.S., and author of "The Pocket Guide to BioIdentical Hormones."  "The surge of information surrounding compounded estrogen creams being touted by celebrities has left many women believing that the only way they can get individualized treatment for symptoms of hot flashes is through compounded pharmacies and that is simply not true since there are a variety of low dose bioidentical estrogens that are FDA-approved."

Compounded bioidentical formulations are often described as "custom" recipes of hormone formulations prepared by a pharmacist following an individual prescriber's order for a specific patient.  Compounded hormone products are not governed with the same type of oversight as commercial bioidentical estrogens that have been FDA-approved so they have not been tested for purity, potency, efficacy or safety.   Bioidentical estrogens that are FDA-approved have been tested according to specific protocols to ensure that they meet stringent guidelines for consistency.  Bioidentical estrogen that is FDA-approved is often also covered by many insurance plans or other patient saving programs.  Women should review their insurance coverage and discuss their options with a healthcare professional.

Traditional compounding is used to prepare medications in such instances as when a patient is allergic to an inactive ingredient in a commercially available product or requires an alternate form of administration. The FDA recognizes the need for this practice, but women should be aware that compounded drugs or formulations are not FDA-approved or tested for quality and potency.

"The bottom line is that if a woman wants to use bioidentical hormones to treat hot flashes from menopause, she should consider the fact that all FDA-approved non-oral estrogen products are also bioidentical and are tested for purity and consistency batch after batch," said Dr. Pollycove.