The phrase “bioidentical hormone therapy” started as a marketing term for custom-compounded hormones. Today, this phrase is used to broadly define hormone replacement therapy. It is also associated with pharmacy compounding and/or blood and saliva testing.
The word bioidentical refers to the hormones in the product that are chemically identical to those your body produces. In fact, the hormones in bioidentical medications may not be any different from those in traditional hormone therapy. Bioidentical hormones do not have to be custom-compounded (meaning custom mixed). Several hormone therapy products approved by the FDA contain bioidentical hormones.
The word natural refers to hormones in the product that come from a plant or animal sources, they’re not synthesized in a lab. Many of these products still need to be commercially processed to become bioidentical. Traditional hormone therapies don’t necessarily exclude natural hormones. Some FDA-approved products which contain estrogens, and Prometrium, a natural progesterone — also are derived from plants.
Some concern has been raised about the use of bioidentical hormone therapy. This debate primarily focuses on the prescription provided by the healthcare provider that calls for a combining of the custom-compounds. This mixture cannot be FDA approved because it is a specific formula mixed to the needs of the individual patient. Therefore it is unable to prove the active ingredients are absorbed appropriately. There is no scientific evidence that indicates these compounded medication are safer or more effective than government approved hormones.
The US Congress, FDA, and other scientific organizations have warned about the potential harm from compounded bioidentical hormones. There is a lack of evidence to support the theory that the benefits and risks of bioidentical hormones are different from well-studied non-bioidentical counterparts. Until this evidence has been produced we should consider the risks to be similar and note that compounded hormone products may have additional risks related to compounding.
The safety concern in bioidentical hormone replacement therapy is the lack of requirement to include package inserts. There is a potential for serious adverse effects, some can be life threatening. Without a package insert a patient will be uninformed and believe that the hormone therapy is safe and without side effects. Regulatory bodies require pharmacies to include important safety information with conventional hormone replacement therapy via package inserts.