Scottsdale – An article 3 days ago in USA Today highlights a problem that appears to be growing each year as women reach menopause and begin using estrogen replacement therapy. A large number of individuals are using custom made estrogen hormone in their formulations from local compounding pharmacies. The FDA and other women health experts believe that these unregulated therapies may cause more harm than good.

A large federally sponsored study demonstrated the risks of hormone replacement therapy in 2002. This prompted millions of patients to try custom-compounded hormones or herbal supplements. These alternative medicines or supplements are especially popular with highly educated women who like to research and find their own solutions to medical conditions. Experts say, however, that these so-called bioidentical formulations that instead of receiving a safer option, most are getting products with unknown risks that may contain potentially dangerous levels of the hormone  estrogen.

Dr. JoAnn Manson, Chief of Preventive Medicine at Brigham and Women’s Hospital in Boston says that, “buyer beware”. She outlines 5 important facts about bioidentical formulations:

1. Bioidentical is a marketing term and has no accepted medical or pharmaceutical definition.

2. The implied benefit is not unique to these alternative treatments. Other prescription drugs contain hormones that match naturally occurring estrogen and progesterones.

3. Custom-compound hormones are not tested or approved by the FDA. They have not been proved safe or effective. Without testing we cannot know if these compounds carry the same cancer and heart risks as previously studied drugs that are not currently recommended because of increased risks.

4. Experts say that standardized dosing systems can work for most people.

5. There is a significant variation in the prescription dose when these are obtained at a compounding pharmacy. Most facilities use different methods for customized prescriptions which cause wide variations in the amounts of hormone contained in their formulations.

6. Many compounding pharmacies may use drugs not approved by the FDA. That is the case with estriol, a commonly used estrogen not approved for sale in the U.S., but widely used by compounding pharmacies.

“Women need to understand there’s no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there’s much less evidence for efficacy and very little research on long-term safety,” said Manson.

Patients should know that, while these products are quite popular, they may not have been made using the strict guidelines for safety and efficacy that is recommended by the FDA. Before recommending treatments for bioidentical hormones from compounding pharmacies, I believe more research is required to identify the risk factors, test for safety and for efficacy.