Doctors are urging women to avoid so-called natural hormone replacement therapy because of health concerns surrounding the therapy.
The therapy, also referred to as bio-identical hormones, has led to elevated hormone levels in some women who underwent that therapy. This in turn could lead to excessive bleeding, blood clots and increased risk of breast and uterine cancer.
According to Dr John Eden, director of the Sydney Menopause Centre at Randwick's Royal Hospital for Women, he had referred two cases of uterine cancer in patients who had been taking natural hormone replacement therapy, to the Therapeutic Goods Administration in the past year alone.
Dr Eden has alleged that these "handmade hormones" were synthesized by compounding chemists without proper scrutiny. In spite of the process being legal, it is beyond the regulatory control of the TGA and state-based pharmacy boards.
He said, "There's a whole stack of women being treated out there with handmade hormones. It's untested hormone replacement therapy.Many women think they are getting a herbal treatment and are shocked to learn they are getting a hormone treatment."
Professional Compounding Chemists of Australia, one of the NHRT's major wholesalers, defended the practice, citing an exemption in the TGA Act that allows the preparation of medicines for individuals.
However, PCCA has acknowledged in a written statement that there was no formal testing of the products.
In the statement they said, "Since compounded products are made on an individual basis according to the needs of a specific patient, it is not possible to test each product before supply to a patient without making the cost prohibitive. Many pharmacies do test samples of products that are made frequently."
These chemists usually make the medication in the form of troches, or lozenges, with the hormones absorbed through the lining of the mouth.
The hormones estrogen and progesterone obtained from yams or soy and prepared in laboratories is present in the NHRT. In addition NHRT can also include the male hormone testosterone that has not been approved in Australia for use on women.
Certain therapies even include thyroid hormone, the controversial sex steroid pregnenolone as well as a steroid called DHEA, that converts to testosterone and is banned from manufacture in Australia.
Dr Helena Teede, research director at Australia's leading women's health organization, the Jean Hailes Foundation has said that many women were not aware that these preparations were not approved by the TGA.
She said, "There has been very limited research into these preparations and women taking the compounds are essentially guinea pigs."