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Hormone Therapy: “Bioidenticals” Can Be Risky

There’s nothing pleasant about sweating through your blouse during an elegant dinner party or having to get up in the middle of the night to change pajamas, but that’s precisely the sort of discomfort faced by many menopausal women.

These symptoms occur due to a reduction in two substances made by a woman’s ovaries (namely, estradiol and progesterone). Historically, symptoms like hot flashes were treated through the use of hormone therapy—that is, the replacement of those hormones depleted in menopause. However, in 2002 and 2004 when the Women’s Health Initiative (WHI) outlined the risks associated with hormone therapy, many women were informed to stop it immediately–even if they had severe symptoms and low risk profiles.

This presented fertile ground for the marketing of alternative treatments to this group of women–who were becoming increasingly hot under the collar, so to speak. One such alternative treatment is called “bioidentical” hormone therapy, which is touted as having the ability to minimize or eradicate the troublesome symptoms of menopause.

But ladies, don’t be too quick on that trigger. While the treatment is marketed with claims that it can restore youthful hormone levels and possibly reverse aging, these are not based in fact.

What Does “Bioidentical” Mean?

First of all, the term “bioidentical” is neither a medical nor a scientific term. It’s a marketing term applied to hormones that are “custom compounded”. The role of a compounding pharmacy is to make drugs (prescribed by doctors) for specific patients with needs that can’t be met by commercially available, FDA approved drugs. An example of this would be if a patient is prescribed a medication which includes ingredients that cause an allergic reaction—in this case, a compound pharmacist could make the proper dosage and form of the drug without the problematic ingredients. The practice of compounding hormones is legal in this country and has been on the rise over the past ten years. There are now approximately 60,000 compounding pharmacies in the U.S.

Are Compounded Hormones FDA Approved?

No. These substances are not approved by the FDA and the manufacturers are not held to the same standards as FDA approved pharmaceutical companies. The problem is that many women who take these so called “bioidentical” hormones are not aware of this fact or the risks associated with it. In 2012, for example, the Centers for Disease Control (CDC) traced an outbreak of fungal meningitis back to a compounding pharmacy in Massachusetts. So how can these still be sold? Compounded hormones for the treatment of menopausal symptoms are classified as “supplements”, not drugs, a legal loophole which allows them to stay on the market.

Talk to your healthcare provider about the risks and benefits associated with hormone therapy. Unless you have very unusual dosage requirements or allergies to all of the pharmaceutical preparations available, stick to the FDA approved medications. There is no good reason to take risks, especially when there are safer alternatives that can help you. Your physician should also be able to provide you with information on some of the new, FDA approved non-hormonal alternatives that are available. Be informed and be careful!

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