An investigative reporter published disturbing findings about compounded hormones in the October issue of More Magazine. Cathryn Jakobson Ramin found that the pills in 12 prescriptions filled at different compounding pharmacies and tested by Flora Research Laboratories in Grants Pass, Oregon, did not contain what they were supposed to: all had less estriol than was prescribed, most had more estrone and estradiol than was prescribed, and nine out of twelve did not contain enough progesterone.
“Had the compounded products we tested been commercially manufactured pharmaceuticals, none would have passed the FDA’s requirements for finished drugs, which mandate that the contents be no less than 90 percent or more than 110 percent of the prescription as the physician has written it,” writes Ramin.
Compounding pharmacies made news after last fall’s tragic meningitis outbreak caused by contamination in a Massachusetts pharmacy. It spurred the US government to draft new legislation that begins to require greater regulation of pharmacy compounding.
That said, compounding pharmacies do provide valuable services in select circumstances. For example, if you are allergic to an ingredient in your medication, a compounding pharmacist can mix a special batch for you that does not contain that ingredient. If you buy medications from a compounding pharmacy, you can check whether your compounder is accredited by the Pharmacy Compounding Accreditation Board at www.pcab.org. Or you can ask your compounder if they do skip lot testing, meaning that they select random products monthly to test for purity and safety. Also be aware that all hormones carry risks and none is approved for anti-aging purposes because there is no adequate evidence to support the claim.
In some ways, this data was disappointing, as it did not support the “window of opportunity” theory that taking HT close to menopause maintains and benefits health. However, this theory does have evidence of benefit regarding women’s risk of cardiovascular disease, coronary heart disease, heart attack, and atherosclerosis.
Here at NAMS, we counsel that the decision of whether to take HT must be individualized for each woman, considering her overall health, severity of symptoms, quality-of-life priorities, and personal risk factors. We know that the risks of HT use in healthy women ages 50 to 59 are low. In older women, however, HT is associated with greater risks: A related WHI trial (WHIMS) found that HT use in women ages 65 to 79 caused a near doubling of rates of dementia, higher rates of cognitive decline over time, and decreased brain volume.
The bottom line of the new WHIMSY results is that younger women can be reassured that, if they choose to take HT for their symptoms, it will not harm their cognitive function or cause dementia.
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JoAnn V. Pinkerton, MD, NCMP