Hot Flash: The Important Facts about Hormone Replacement Therapy

Recently the FDA issued a safety alert regarding combination oral contraceptives that contain the progestin drospirenone. The FDA is investigating whether there is a greater risk for blood clots. The products that contain drospirenone include Yaz, Beyaz, Safyra and Yazmin.

For those physicians who use bioidentical hormones, this FDA alert comes as no surprise. Almost 10 years ago, in 2002, the now famous Women’s Health Initiative (WHI) study looking at synthetic estrogens (conjugated equine estrogens like Premarin) and progestins (synthetic progesterone like Provera) was stopped because of the increase breast cancer, heart disease, stroke, and yes blood clots.

This risk is nothing new. A synthetic hormone like drospirenone is not a bioidentical. A bioidentical hormone is one that looks chemically and structurally exactly like our own hormones in our body. Synthetic hormones do not. In the wave of the WHI, women stopped taking their hormones and sought alternative treatments. They demanded and received bioidentical hormones. Many received their hormones from compounding pharmacies. If lucky and they had a good pharmacy, they received relief from their menopausal symptoms such as hot flashes, night sweats, insomnia, weight gain, depression and vaginal dryness.

The pharmaceutical industry, realizing the enormous amount of money to be made, entered the bioidentical market. Although a bioidentical hormone cannot be patented the way it is administered may be.In other words evamist, which contains bioidentical estradiol is a topical spray- the pharmacy was able to patent the spray and was allowed to use it to put in estradiol. Prometrium, or bioidentical micronized progesterone is capsule made in peanut oil- this was a new way of making a capsule and the drug company was permitted to put progesterone in it. Thus the pharmaceutical industry was able to break into the bioidentical hormone market and receive FDA approval.
Many patients are not aware that there are FDA approved bioidenticals. Although the word bioidentical is frowned upon by traditional physicians, if one looks at some of the inserts for FDA approved “identical” hormones, the word bioidentical is used. FDA approved bioidenticals include gels, sprays, patches, pills and vaginal inserts.

So why so much confusion? Why aren’t all physicians using the FDA approved bioidenticals? The answer is lack of education and time. I still see patients on Premarin and Provera. I recently saw a patient who was a smoker and on these synthetic hormones!! Since smoking increases the risk of strokes and blood clots, this combination is particularly dangerous.
I believe in the use of only bioidentical hormones. There is a lot of research backing up the usage of bioidenticals over synthetic. I advocate both FDA approved products and if need be compounded products. The FDA approved products come only in certain dosages and many patients are able to achieve relief with lower doses. I always try the lowest dose in an attempt to alleviate menopausal symptoms.
Regardless of what type of hormones one uses (but please –not synthetic!!!), one should always be evaluated by a physician with blood tests, bone density and pelvic ultrasound.

Dr. Dean Mitchell
Mitchell Medical Group, NYC & Long Island

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