Dangers of Tri-Estrogen Cream

Tri-estrogen cream is a hormone replacement therapy. It is a combination of the three major estrogens: estradiol, estrone and estriol. It is a compounded drug, which means it is prepared, mixed, packaged and labeled by a pharmacist. Typically, tri-estrogen contains a ratio of 10 percent estradiol, 10 percent estrone and 80 percent estriol. The dangers associated with tri-estrogen are similar to those associated with other forms of estrogen therapies, according to the FDA. The FDA also warns that tri-estrogen cream, like other compounded drugs, may have additional risks intrinsic to compounding.

• Tri-estrogen is formulated at compounding pharmacies.

History

• The dangers associated with tri-estrogen cream largely stem from the fact that there have not been any long-term studies conducted on it. Tri-estrogen is one of several so-called bioidenticals that are not approved by the FDA. Experts argue that tri-estrogen may carry more risks than other FDA-approved hormone replacement therapies because it is not regulated, and it has not been scientifically tested for efficacy.

Dangers

• Though the idea behind tri-estrogen is to balance the stronger estrogens that carry higher cancer risk (estradiol and estrone) with the weaker estrogen (estriol), estrogens have been reported to increase the chance of endometrial cancer in postmenopausal women. Estrogens, like those found in tri-estrogen cream, may also increase the risk of ovarian or breast cancer. In The Menopause Sourcebook, Dr. Adriane Fugh-Berman says, "There is no solid evidence that Tri-Est is safe for the endometrium or breast tissue."

Potential Risks

• Tri-estrogen is also a compounded drug. Unlike pharmaceuticals that are approved by the FDA to be manufactured and sold in standardized dosages, compounded medications often are custom made for a patient according to a physician's specifications. Most compounded products have not undergone any rigorous clinical testing for either safety or efficacy, and issues of quality assurance regarding the purity, potency and quality of compounded products are a concern.

Warning

• The FDA also warns that because compounded products are not approved by the FDA and have no official labeling, they are exempt from including the contraindications and warnings required by the FDA in class labeling for hormone therapy.

Other Safety Issues

• Additionally, the FDA advises that given the lack of well-designed and well-conducted clinical trials of alternative therapies, such as tri-estrogen, compounded hormone products should be considered to have the same safety issues as those associated with hormone therapy agents that are approved by the FDA. The product inserts of FDA-approved hormone replacement therapies state they can also increase user's risk of heart disease, breast cancer, stroke and blood clots.