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  • Writer's pictureLawrence Hutchison

Is Bio-identical Hormone Replacement Safe?

Updated: Apr 13, 2022

Hormones are the bodies chemical messengers that tell other parts of the body how and when to work. Hormones control almost all tasks in the body. These include sex and brain function, growth and the breakdown of food. When hormones are out of balance, or depleted symptoms often occur.

Bio-identical hormones are defined as those hormones that are molecularly identical to the natural hormones produced by the human body. The most commonly used biogenetical hormones are estrogen, progesterone and testosterone.

Some prescription forms of bio-identical hormones are pre-made by a drug company. Other forms are custom-made or compounded by a pharmacist based on a doctor’s order. The US Food and Drug Administration (FDA) has approved a number of preparations of bio-identical estradiol and progesterone. Their compounded forms have not been tested and approved by the FDA, as the relative strength and ratio of hormones is customized for each patient, though many of the compounded formulations are mixtures of FDA approved preparations. Many of the more popular compounded preparations are made from naturally occurring molecularly identical hormones found in plants, and thus are not under FDA regulation.

Many experts believe that customized bio-identical hormone preparations are as safe as FDA controlled formulations, and often appear to be more effective, feel more natural, and provide for an individualized alternative to conventional hormone therapy. Bio-identical compounded hormones have been in use for over 70 years with no evidence that they are inferior to or more dangerous than FDA controlled alternative.

Compounded hormones come in an endless variety of customizable doses and routes of delivery (pellets, pills, creams, gels, sprays, sublingual drops and vaginal inserts). Some concern exists because of the potential for variability in preparation and formulation which are provider and pharmacy dependent. However, experts across the country agree, that in the hands of an experienced provider using a reputable pharmacy following the highest quality compounding practice standards, any theoretical risk is likely out-weighted by the many benefits.

~Dr. Lawrence Hutchison, MD, Medical Director at Statera

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