What Women Need to Know about “Bio-identical Hormones, Custom-Compounded Hormone Therapy and Hormone Pellets–FDA Advises Caution

Pleasant middle aged woman hugging kneesNearly twenty years have passed since the Women’s Health Initiative (WHI) announced serious safety concerns involving hormone replacement therapy during menopause. Since then, we have come to understand that these early conclusions were based on an incomplete understanding of the study’s data. Unfortunately, the announcement caused panic among American women. Nearly half of them gave up hormone replacement within a few months. Women whose menopausal symptoms reduced their quality of life resigned themselves to suffer in silence.

With better information, women have now reached a more balanced understanding of the benefits and possible risks of hormone replacement therapy (HRT). HRT is the most effective treatment for hot flashes and vaginal dryness, and it has been shown to reduce bone loss and fractures. For women age 60 or younger or those who are within 10 years of the start of menopause (excluding women with special risk factors), the benefits of HRT make it a good choice when symptoms interfere with quality of life. In this age group, the risks of HRT are low. (Click here for a more information on this topic).

Many more women are again interested in hormone therapy to control uncomfortable symptoms. We offer them up-to-date information and reassurance about safety. But a large and profitable market has sprung up preying on women’s safety concerns by offering “safer” and more “natural” alternatives to FDA-approved medications. I strongly agree with the view of the North American Menopause Society (NAMS) that—

…there is no scientific evidence that these custom compounded medications are safer or more effective than government-approved hormones. NAMS supports the actions of the US Congress, FDA, and other scientific organizations that have warned about the potential harm from compounded bioidentical hormones.

I recommend this five-minute video about non-FDA approved hormones. It explains the issue in an easy-to-understand way.  It also describes serious safety concerns about some of these products:

  • These products are not FDA tested to verify their active ingredients and dosages, nor to ensure that they are free of dangerous impurities.
  • “The phrase bioidentical hormone therapy has been recognized by the FDA and the Endocrine Society as a marketing term and not one based on scientific evidence.” (American College of Obstetrics and Gynecology). The term implies to women that this medication is safer or has other benefits when, in fact, reliable science does not support these claims.
  • Over or under-dosing (the estrogen/progesterone balance) can increase the risk of uterine cancer. The FDA is investigating evidence that thousands of malignancies in women receiving non-FDA approved hormones may not have been reported.
  • Custom-compounded products do not contain a “black box warning” alerting women about possible risks and side effects. Some mistakenly believe that the absence of the warning panel means the product is safer. Actually, it only means that unregulated products are not required to put warnings on the label.
  • NO HORMONE PELLETS (hormones injected under the skin) HAVE FDA APPROVAL. This is because pellets deliver inconsistent levels of hormones to the body. They may contain potentially harmful doses of estrogen and/or testosterone.
  • Rarely, custom-compounded hormones may be prescribed for a woman with a specific medical need for which a suitable commercial product is not available. This would be unusual because of the large variety of FDA-approved products now available to address individual needs. The physician who prescribes custom-compounded medications bears the responsibility of alerting the patient about the reason for the prescription and the product’s potential risks and side effects.

With limited exceptions (some immunizations, RhoGAM, samples, etc.), we do not dispense medications in our office. Any medication do we dispense in the office is FDA approved. For most medications, we write a prescription for an FDA-approved product that you purchase from your pharmacy. We DO NOT SELL dietary supplements such as weight-loss products, herbal product, enzymes, etc. Dietary supplements are not regulated by the FDA. We do not participate in marketing products that have not shown medical benefit, based on scientific research. We caution you to be aware of the profit motive when such products are recommended.

We appreciate and respect your trust in the care we provide.

Jimmy M. Sparks MD