Women Fooled By Untested Hormones From Compounding Pharmacies

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According to a new study, an estimated 28 million to 39 million prescriptions are filled each year for hormone-replacement therapies made by compounding pharmacies. But two large Internet surveys reveal that a staggering 86% of women don’t understand that products sold by compounding pharmacies are not approved by the U.S. Food & Drug Administration.

This is a disturbing but not entirely surprising revelation. Compounding pharmacies have made a rollicking business catering to women in menopause who are seeking relief from symptoms such as hot flashes and insomnia. These pharmacies manufacture their own versions of hormones such as estrogen and progesterone, and then market them as “bioidentical” or “natural” products based on the fact that they are derived from botanical sources like soy and they mirror the hormones that women’s bodies make naturally.

The study, published online in Menopause, the journal of The North American Menopause Society (NAMS), compiled results from two surveys of 3,000 women. When asked “Do you believe that bioidentical hormone therapies compounded at a specialty pharmacy are FDA approved?” only 14% of the women correctly said “no,” according to NAMS. Of the rest, 10% said “yes” and the rest didn’t know.

What this large contingent of misinformed women may not understand is that products made by compounding pharmacies do not have to adhere to the same manufacturing quality requirements and strict oversight that FDA-approved products face. The dangers of that became all too clear in 2013, when contaminated steroid products made by a compounding pharmacy in Massachusetts sickened more than 740 people, 64 of whom died.

The incident prompted the passage of federal legislation giving the FDA more authority—but not complete control—over compounding pharmacies. The Drug Quality and Security Act offers compounders two choices: they can either register as “outsourcing facilities” with the FDA and become subject to quality control rules similar to those governing large drug manufacturers, or they can sidestep that restriction on the condition that they only compound individual prescriptions for one patient at a time. (No mass producing or mass marketing allowed, in other words.)

That may help lower the contamination risk, but compounded drugs often have other shortcomings. Testing of 12 compounded hormones by More magazine found that levels of some hormones were often lower or higher than what was prescribed. In 11 of the samples, progesterone levels were too low. That’s dangerous: progesterone protects the lining of the uterus, which in turn lowers the risk of endometrial cancer in women taking estrogen for hormone replacement.

http://www.forbes.com/sites/arleneweintraub/2015/02/20/women-fooled-by-untested-hormones-from-compounding-pharmacies/