Health care providers usually prescribe bio-identical hormones to stabilize or increase the amounts of women's hormones before and after menopause, reports WebMD. Pharmacists compound, or custom make, bio-identical hormones in capsules, tablets, skin creams, suppositories and other forms. However, the U.S. Food and Drug Administration has not approved bio-identical hormones, and no evidence exists that they are safer or more effective than traditional approved hormone therapy, points out Mayo Clinic.
The claims of those marketing bio-identical hormone products may mislead health care providers and women into supposing that using them provides an increased measure of safety over approved products, but this is not true, warns the FDA. As of 2015, no bio-identical hormones have undergone the lengthy evaluation process to meet FDA standards. Although the FDA allows compounding of drugs to meet the needs of individuals, it cannot verify that pharmacies provide the correct hormone levels or quality of binding ingredients. Creating individual bio-identical hormone mixtures based on saliva samples is ineffective because women's hormone levels change constantly.
Using either traditional hormone therapy or bio-identical hormones may carry the same increased risk of breast cancer, heart disease, stroke and dementia for some women, explains the FDA. Adverse side effects of bio-identical hormones are unknown because regulations do not require pharmacies to report them.