Bio-identical hormones are treatments produced in a compounding pharmacy that are designed to work in the same manner as natural hormones. Women experiencing severe or uncomfortable side effects from menopause typical use hormone replacement therapy. Body builders and those looking for ways to reduce the signs of aging also use synthetic hormones. Little scientific research is available on bio-identical hormones and their potential side effects.
The Food and Drug Administration does not regulate bio-identical hormones; therefore, little is known about the side effects and benefits of the drugs. Random tests have shown vast disparities in the drugs' contents. Experts at the Endocrine Society say that replicating hormones is difficult because individual hormone levels fluctuate rapidly within individuals. The medical experts at the Endocrine Society are calling for more research and monitoring of the possible side effects before they support the use of the synthetics.
Because bio-identical hormones are often produced under unregulated practices, the market has seen a number of counterfeit and misleading products. According to the Breiner Whole-Body Health Center in Connecticut, the chemical differences in counterfeit drugs could cause substantial side effects such as headaches, tender breasts, weight gain, loss of libido and mood swings. Progestin bio-identicals can cause depression, nausea and water retention.
Although doctors and homeopaths individualize the patient's prescription, there are no measures to monitor the drugs' efficacy, dosage consistency or safety. Controversy continues over the levels of risk in compounded treatments. Proponents of the practice say it reduces the risk of getting breast cancer, while others say it can increase the risk.
The FDA has received reports of serious side effects, including death from improperly compounded bio-identical hormone drugs. The federal regulatory agency reports that many compounding pharmacies provide consumers with false advertising about the side effects of their bio-identical hormone treatments. They say that most studies have shown that bio-identicals carry the same risks as approved pharmaceutical hormone replacement drugs that include an increased risk for breast cancer. Other false advertising the FDA has encountered include claims that compounds can help prevent cancer, cardiovascular and Alzheimer's disease.
The American Medical Association, while being accused of supporting the pharmaceutical companies for profit, supports the FDA findings that until there are more studies done on the side effects of bioidentical hormone replacement drugs, its membership cannot condone their use. Still unsure of the potential side effects, other groups that have withheld support include the American College of Obstetricians and Gynecologists and the National Institutes of Health.