Bioidenticals
False claims have become very common- seldom answered.
ACOG NEWS RELEASE
| For Release: | October 31, 2005 |
| Contact: | ACOG Office of Communications |
| (202) 484-3321 | |
| communications@acog.org |
Washington, DC — There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies, according to a new Committee Opinion released today by The American College of Obstetricians and Gynecologists (ACOG). Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing. ACOG’s opinion also points out that salivary hormone level testing used by proponents to ‘tailor’ this therapy isn’t meaningful because salivary hormone levels vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables.
Compounded “bioidentical hormones” are plant-derived hormones that are prepared, mixed, assembled, packaged, and labeled as a drug by a pharmacist. These preparations can be custom made for patients according to a physician’s specifications. “Bioidentical hormones” refer to hormones that are biochemically similar or identical to those produced by the ovaries or body.
According to ACOG, most compounded products, including bioidentical hormones, have not undergone rigorous clinical testing for either safety or efficacy. Also, there are concerns regarding the purity, potency, and quality of compounded products. In 2001, the FDA analyzed a variety of 29 product samples from 12 compounding pharmacies and found that 34% of them failed one or more standard quality tests. Additionally, 9 of the 10 failing products failed assay or potency tests, with all containing less of the active ingredient than expected. In contrast, the testing failure rate for FDA-approved drug therapies is less than 2%.
The FDA requires manufacturers of FDA-approved products that contain estrogen and progestogen to include a black box warning that reflects the findings of the Women’s Health Initiative. However, compounded products, including bioidentical hormones, are not approved by the FDA and therefore, compounding pharmacies are exempt from including warnings and contraindications required by the FDA in class labeling for hormone therapy.
Given the lack of well-designed and well-conducted clinical trials of these compounded hormones, ACOG recommends that all of them should be considered to have the same safety issues as those hormone products that are approved by the FDA and may also have additional risks unique to the compounding process.
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Committee Opinion #322, “Compounded Bioidentical Hormones,” is published in the November 2005 issue of Obstetrics & Gynecology.The American College of Obstetricians and Gynecologists is the national medical organization representing over 49,000 members who provide health care for women.