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Confused About 1/29/09 Oprah’s Show? Natural Hormones ARE Regulated

Posted Apr 09 2009 7:15pm

In Oprah’s last hormone show an unnecessary battle waged over the safety of compounded hormones. On her show it was insinuated that compounded hormones  are not regulated. But that is just plain false. I often have to clarify this (see below) and it’s too bad because it detracts from the bigger picture which is that hormones should be used, and can be used safely to live a longer, happier, and more satisfying life. 

All women can safely use natural bioidentical hormones, FDA regulated or pharmacy regulated, to improve sleep, moods, energy, memory, bones, heart, skin, and sex drive. My website lists all of the symptoms of low hormones. You don’t need fancy tests to start. All doctors are capable of prescribing natural bioidentical hormones. Here’s how:

  1. To support estrogen: Ask your doctor for Estradiol (FDA regulated patches, gel, or mist, or compounded Estradiol lotion). The patches can itch and fall off but many women love them as they only require changing every 3 days. All FDA approved treatments are prescribed at a specific dose so they don’t work for all women. That’s where compounding lotions are helpful. Compounding pharmacies make estradiol in lotions that allow you to vary doses. This is particularly helpful in perimenopause and early menopause when estrogen levels are very changeable.
  2. Always balance estradiol with natural progesterone, even if you have had a hysterectomy. Natural progesterone is available in FDA approved oral capsules or vaginal cream. It can also be compounded into oral capsules, skin lotions/creams, or drops (taken under the tongue). Chapter 8 in my book discusses progesterone. If you are on too much estrogen or if you start and stop progesterone, you may bleed or spot, which you should discuss with your doctor, whether you are using FDA approved hormones or compounded.
  3. Many insurance companies cover bioidentical natural hormones. If finances are a problem talk to your pharmacist about price options as insurance coverage may vary. If insurance is not covering your compounded hormones ask your insurer which compounding pharmacies they do cover. Most insurance companies have an affiliated compounding pharmacy.
  4. All Compounding pharmacies are regulated.   Compounded hormones can not be FDA approved because they do not come in standardized doses. Instead, they are  regulated by state boards of pharmacy. The materials that make up the compounded medications are all sourced from licensed FDA-registered manufacturers. To learn more about this visit the IACP (International Academy of Compounding Pharmacy) website.
  5. All compounding pharmacies are not equal. They are not monitored as to how much hormone is actually delivered in their products. This is why you hear so much (unfair) criticism of compounded products. To ensure quality, many compounding pharmacies routinely submit their products to independent labs for testing to establish that their creams contain what they say. Ask if your pharmacy does this.  Better yet, remember, “the proof is in the pudding.” If your symptoms improve with the product, then the product is doing it’s job. If you are not improving, talk to your doctor about increasing your dose, that is after all why you are using a compounded product- to match your individualized symptoms with your individualized needs.
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