Compounded Hormone Products Are a Big Business – Medical Groups Raise Concerns

According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income.  The article provides an estimate of $1.3 -1.6 billion annually.

With the flurry of FDA enforcement actions on pharmacy compounders, some are questioning the safety of this segment of the burgeoning industry.  FDA-approved products come with mandated patient package inserts that describe in detail the potential serious adverse events, warnings and contraindications with the use of such products.  It is not clear what information a patient may receive when getting a compounded hormonal product for menopause.  Remember, this class of FDA-approved drug products also contains black box warnings. This could raise significant liability for the compounder relative to failure-to-warn concerns.  Without the appropriate patient package insert, it could also result in a patient experiencing an adverse event from delaying treatment or discontinuation of therapy.

There are also questions of batch-to-batch bioavailability of such products and reproducibility of the compounding process for such powerful drug products.   Patients may also experience differences in product performance if they switch from one compounding facility to another.  These are historical issues that are raised from the use of compounded products, in general, and one of the reasons that FDA has taken action against many unapproved marketed prescription products over the years and why FDA and the states have cracked down on compounding pharmacies and facilities.

The study referenced in the article concluded that physicians should take appropriate steps in educating their patients using compounded hormone replacement therapy.   Good advice for sure!  We will try to keep an eye on any developments in this area for you.