OTC Progesterone use raises concern

Researchers are concerned women using Over The Counter (OTC) Progesterone products may be exposing themselves to risk without the counseling, screening and supervision that accompany the use of prescription progesterone products.

The June 2005 Journal of Clinical Pharmacology published a study recently published which found substantial evidence that OTC topical progesterone results in similar drug exposure as a result of skin absorption as taking a prescribed oral progesterone product.

The study was supported by Bassett Healthcare, led by Drs. Anne C. Hermann, Anne Nafziger and Joseph Bertino. The study was based upon twelve, healthy, post-menopausal women which were treated with topical OTC progesterone ( Pro-gest cream ) in one phase and then were prescribed oral progesterone ( Prometrium ) in the other phase of the study.

The results of the study showed that there were no differences between the two groups in the amount of progesterone exposure in the body. Regardless of the source of the progesterone, women involved in this study experienced similar rates of adverse effects.

The American College of Clinical Pharmacology has expressed considerable concern about the risk that many over-the counter (OTC) cosmetic preparations may pose to the public as since many of these cosmetic preparations are not regulated by the FDA are used without any medical supervision.

Commonly prescribed to women Progesterone used in hormone replacement therapy (HRT) in postmenopausal women, and for the treatment of amenorrhea, infertility and premature labor. Past studies revealing the health risks of HRT causing a dramatic declines in prescriptions for these products. Natural progesterone in the form of herbal beauty creams continues to be sold over-the-counter exempted from regulatory scrutiny.