The current tragic situation regarding
contaminated compounded steroid injections causing stroke and death should
alert women to the danger of using mass produced compounded bioidentical
hormones as a menopause therapy.
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.
RISKS FOR PHYSICIANS AND NURSES
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.
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
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/