Date Published: 17 July 2005

Study on OTC progesterone risks - Progesterone in some Herbal Beauty Creams

Health News from the United States of America (USA)

The Journal of Clinical Pharmacology (June 2005 ), published summary results of a study in which researchers found evidence that use of over-the-counter (OTC) topical progesterone results in similar drug exposure through skin absorption as that which results from taking a prescribed oral progesterone products.

This study may be considered in the context of existing concerns that some OTC cosmetic preparations may pose some risk to the public because many of these are not regulated by the FDA, and are commonly used without medical supervision.
This type of concern also applies to many other creams, supplements, and other OTC products. There are two broad opinions on this subject: Some people support the public's right to purchase products according to individuals' own discretion (taking personal responsibility for researching uses, side-effects, and possible contra-indications of non-pharmaceutical products). Others believe that government and regulatory bodies should be primarily responsible for ensuring that potentially "unsafe" products are not available for purchase in order to protect the public from any possible side-effects. Difficulties with this issue include the fact that many substances, even some of those essential for healthy living, can also be harmful if consumed in excessive quantities.

A research article entitled "Over-the-Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration-Approved Oral Progesterone Product" recently published by the Journal of Clinical Pharmacology concerns the hormone progesterone, which is commonly prescribed to women, is often used in hormone replacement therapy in post-menopausal women, and for the treatment of amenorrhea, infertility and premature labor.

Past studies revealing the health risks of FDA-approved hormone replacement therapy (HRT) - including oral progesterones and progestins, have contributed to a reduction in prescriptions for these products. One reason for this is that the publicity arising from these studies has resulted in some women questioning their doctors about the benefits and risks of HRT, and seeking natural alternatives. However, unregulated natural progesterone is also sold over-the-counter in the form of herbal beauty creams, thus exempting them from regulatory scrutiny. Although increasingly aware consumers of food and health products are becoming more likely to read labels on food and supplement products, it is possible that some purchasers may not realize that hormones may be present in herbal beauty creams - and so may not be reading the labels of these products, or know what to look for if they did.

Considering the risks associated with prolonged progesterone therapy, the researchers note that women may be exposing themselves to similar risks without the counseling, screening and supervision that accompany the use of prescription products.

Source: The Journal of Clinical Pharmacology, official journal of the American College of Pharmacology. www.jclinpharm.org

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