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FDA Takes Action Against Compounded HRT
FDA Takes Action Against Compounded HRT

FDA Takes Action Against Compounded HRT

In a blow to certain drug makers, the FDA has sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called “bio-identical hormone replacement therapy,” or “BHRT” products are unsupported by medical evidence, and are considered false and misleading by the agency. According to the FDA, they are concerned that unfounded claims like these mislead women and health care professionals.

Bioidentical hormones are custom-mixed formulas containing various hormones that are designed to be chemically identical to those naturally made by your body. These prescription and over-the-counter products are marketed as being superior to other FDA-approved HRT regimens, and are tailored to a woman’s individual hormone needs, typically determined through saliva hormone testing. Manufacturers claim that bioidentical hormones are even safer than standard, FDA-approved hormone therapy.

The FDA states that the pharmacy operations in question improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer’s disease, stroke, and various forms of cancer.

The FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and the FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters issues by the FDA state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

“We want to assure that Americans receive accurate information about the risks and benefits of drug therapies,” said Dr. Janet Woodcock, FDA’s chief medical officer and acting director of the agency’s Center for Drug Evaluation and Research. “In addition to today’s regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies.


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