Compounded bio-identical hormone therapy

The prescribing and dispensing of compounded hormonal products often described as ‘bio-identical’ is common across Australia and appears to be increasing. This has significant public health implications for Australians.

These hormones are often prescribed for menopausal symptoms, thyroid disease, male hormone deficiency and other hormonal conditions.

Doctors who prescribe these ‘bio-identical’ hormones describe them as being identical to hormones made by the body and that these "natural" capsules, creams, lozenges (troches) and gels are without the risks of hormone therapies approved by the Australian drug regulators (the Australian Therapeutic Goods Administration or TGA). Often they are no different from TGA approved options such as TGA approved oestrogen or progesterone therapy for women and testosterone for men.

Specific concerns are:

  1. These are more expensive than TGA approved therapies yet compounded hormone therapy has never been properly tested.
  2. The doses are mostly estimates with no research having previously shown what doses are effective or safe. For example, if a woman is prescribed compounded oestrogen for menopausal symptoms no studies have been conducted to work out how much compounded progesterone is needed to protect the lining of the uterus from thickening and developing cancerous changes.
  3. There is no independent testing of the dose accuracy or the purity of what is made up.
  4. Unlike other approved medications these do not have to come with patient treatment information or safety warnings - consumers are not warned of risks.
  5. The compounding pharmacies acting as pharmaceutical companies but are not being governed by the regulations that govern the pharmaceutical industry. Because they are “dispensing” on prescription they are able to skirt around the laws that would normally apply to the production of controlled substances such as testosterone and oestrogens.
  6. The promotion of hormones NOT approved for use in Australia such as DHEA, melatonin and pregnenalone for which there is no evidence to support use.
  7. The combination of several hormones in one treatment.
  8. The inappropriate prescription of hormones made by the adrenal glands (hydrocortisone) to people who have normal adrenal function and pig/ beef thyroid extract, often prescribed to people with normal thyroid function.
  9. The misinformation being disseminated to the community:
    a. that ‘natural menopausal hormone therapy’ is safer than approved pharmaceuticals and will do no harm. There is no evidence that compounded sex hormone therapy is more or less safe than other therapies.
    b. that doses are custom-formulated on the basis of salivary hormone levels- the validity of salivary tests for sex steroids has not been established.

If you are offered compounded hormone therapy ask why you cannot have treatment with a therapy that has been tested for dose and safety and approved by the TGA