BIOIDENTICAL HORMONES REALLY SAFE?
The concept of bioidentical hormones, popularized by the likes of Suzanne Somers and Oprah Winfrey, has created real confusion. While the term has been used to refer to many well-tested, regulatory (FDA) approved, brand-name HT products containing hormones chemically identical to hormones produced by women (primarily in the ovaries), such as estradiol or progesterone, in the wider medical market it has assumed a different meaning. It is most often used to prescribe custom-made HT formulations (called “bioidentical HT”, or BHT) that are compounded for an individual according to a healthcare provider’s prescription.
It cannot be adequately emphasized that the FDA has not tested these products for efficacy or safety, and they are not approved by any regulatory agency. Indeed, safety information is not consistently provided to women along with their prescription, as is required by the FDA with commercially available HT products (the patient package insert). Moreover, batch standardization and purity may be uncertain (is this month’s prescription identical to last month’s?).
The FDA has actually sample-tested products from some compounding pharmacies and found unapproved contaminants, dosing errors, and other problems. As a result the FDA ruled that compounding pharmacies have made claims about the safety and effectiveness of BHT that is unsupported by clinical trial data and therefore considered to be false and misleading. The FDA has also stated that there is no scientific basis for using saliva testing to adjust hormone levels.
Much of the motivation behind this industry is explained in one word – PROFIT. Indeed the cost of the medications to women could be an issue. Medical insurance companies view many compounded products as experimental drugs and will not cover the cost.
MEDICO-LEGAL RISKS FOR PHYSICIANS AND NURSES
The prescribing of compounded drugs involves the triad of patient, physician/nurse prescriber, and compounding pharmacy. When prescribing an FDA-approved drug according to acceptable indications, in the event of an adverse outcome the nurse/physician is invariably indemnified by the FDA approval process and background support of a major pharmaceutical company, thus unlikely to face personal liability.
Compounders, unlike with FDA-approved products, are not required to provide a patient package insert listing risks and benefits, and their marketing invariably has minimized possibility of risks. Consequently, prescribers of compounded products would be personally exposed should there be an adverse event as a result of administering a product for which neither the prescriber or compounder can prove to have been pure and free of active contaminants, of correct dose, sterile etc. Providers should also be aware that the liability for using a non-FDA-approved drug can be significant, and possible negative consequences can include the invalidation of their malpractice insurance, personal liability, and possible criminal prosecution.
You can immunize yourself to a large extent against malpractice exposure. The simple and direct approach would be to only prescribe FDA-approved products.
Hopefully the extent of the current compounding drug tragedy can be contained.
The bottom line is that for virtually all women with indications for therapy, FDA-approved HT will provide appropriate “bioidentical” therapy without the risks and cost of custom compounded preparations. Simply put, buyers beware!
Next week I will explain the breaking news on the KEEPS and DOPS studies, and their implications for use of hormones after
Have a great week
Wulf Utian MD PhD DSc
CHANGE YOUR MENOPAUSE – Why one size does not fit all. http://www.amazon.com/Change-Your-Menopause-size-does/dp/0982845723/