Because consumer laws do not require pharmacists who mix individualized bioidentical hormones to report adverse reactions to compounded drugs, the side effects are unknown as of 2015, explains the U.S. Food and Drug Administration. The FDA has not approved any bioidentical hormone products due to lack of data from long-term studies, and these products may have the same side effects as standard menopausal hormone therapy products, including heart attacks, stroke, blood clots, breast cancer and gall bladder disease.Continue Reading
Companies that market bioidentical hormone products claim that they are more natural than standard FDA-approved hormone products, but no evidence supports this assertion, according to Mayo Clinic. A number of FDA-approved products also derive hormones from natural sources such as plants, and bioidentical hormone products are not completely natural, as they must undergo a measure of commercial processing. Additionally, although bioidentical hormone marketers claim the products are custom-made based on saliva assessments, the hormone readings in saliva samples do not indicate the needs for managing menopausal symptoms. Women's hormone levels fluctuate constantly during the day and are inaccurate indications of dosage requirements for hormone therapy, notes the FDA.
As of 2015, although the FDA has not removed bioidentical hormone therapy products from the market, it emphasizes that studies have not proven them to be safe and effective, states the FDA. Marketers' claims that they prevent breast cancer, heart disease and dementia are misleading and unfounded. No study has proven the hormone estriol safe for use, and the FDA does not approve of any compounded bioidentical hormone product that contains estriol as an ingredient.Learn more about Side Effects