ETIQ

Bioidenticals

There are two types of hormone formulations available for women suffering from symptoms associated with menopause:

  1. Traditional hormones – derived from animal byproducts or plant sources that are not an exact match chemically to what a woman’s body produced before menopause
  2. Bioidentical hormones – derived from plant-sources, but an exact match chemically to the hormones produced by a woman before menopause

Where confusion occurs is that there are two types of bioidenticals.

Bioidentical Estrogen Therapies That Are FDA Approved
Bioidentical hormones are made by chemically changing a hormone-like substance from another source – for example soy or yams – to make it exactly the same structure as the hormones produced in your body. x The FDA has approved several safe and effective bioidentical estrogen therapies for the treatment of moderate-to-severe hot flashes associated with menopause.xv

Compounded Bioidentical Estrogen Formulations That Are Not FDA Approved
Traditional compounding is used to prepare medications in such instances as when a patient is allergic to an inactive ingredient in a commercially available product or requires an alternate form of administration. The FDA recognizes this, but women need to be aware that compounded drugs are not FDA approved or tested for quality and potency as are FDA-approved drugs.xii

Compounded biodenticals are often described as “custom” recipes of hormone formulations prepared by a pharmacist following an individual prescriber’s order for a specific patient. These formulations have not been approved by the FDA and as a result, have not been tested for purity, potency, efficacy or safety.xii

Compounded bioidentical estrogen formulations have no FDA-approved label with an indication for the treatment of menopausal symptoms unlike commercially available, pharmaceutical-manufactured, FDA-approved estrogen products.

There is a common misconception that compounded estrogen is the only option available for “individualized” treatment. FDA-approved estrogen therapies are available in a wide variety of dosages and delivery methods, including oral, gel, patch, spray, lotion and vaginal ring form.

Cost Differences
There are also misconceptions surrounding the cost difference of compounded bioidenticals and bioidenticals that are FDA approved. Compounded bioidentical formulations are not necessarily cheaper than bioidentical estrogen therapies that are FDA approved. Often, bioidentical estrogen that is FDA approved is covered by many insurance plans or other patient saving programs. Women should review their coverage and discuss their options with a healthcare professional.

For women who want to be empowered
with credible facts about estrogen therapy.