FDA & Bioidentical Hormones


Bioidentical Hormones

What does the FDA say about Bioidentical Hormones?

There are many theories about Bioidentical Hormones and if they are or aren’t FDA approved. We encourage our patients to do their research regarding Bioidentical Hormones.

In letters addressed to seven pharmacy operations, the FDA warned that the claims made regarding the safety and efficacy of compounded “bio-identical hormone replacement therapy” drugs are considered false and misleading and are unsupported by medical evidence.
These pharmacy operations also compound hormone therapy drugs that contain estriol. No drug containing estriol has been approved by the FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.
False and misleading claims
“The action will help to inform professionals and their patients that some compounding pharmacies are incorporating an unapproved estrogen (estriol) in compounded products prepared for the treatment of menopausal symptoms,” Scott Monroe, MD, director of the agency’s division of reproductive and urologic products, Center for Drug Evaluation and Research, told Endocrine Today.
The companies being warned claim their drugs are superior to menopausal hormone therapies approved by the FDA and that their therapies prevent or treat diseases like Alzheimer’s disease, stroke and multiple forms of cancer.
According to the FDA, the term “bio-identical,” implying a substance that is natural or identical to those made by the body, is a marketing claim that denotes a benefit for the drug when, in reality, there is no reliable medical or scientific support for such a claim.
The FDA is not aware of any credible scientific evidence supporting these claims. Nor is the FDA aware of sound evidence showing that the side effects and risks of compounded “bio-identical” drugs that use estrogen and progesterone as active ingredients are different than those of similarly formulated FDA-approved menopausal hormone therapy drugs.
Because many claims regarding safety, efficacy and superiority of compounded drugs have not been proven, the FDA is concerned that these claims mislead patients and practitioners. Compounded products that have identical chemical structures to FDA-approved hormone drugs can be expected to have the same benefits, and risks, associated with FDA-approved hormone therapy.
Serious consequences
Injunctions to prevent further violations and the seizure of violative drugs are among the risks faced by companies who fail to appropriately address the violations stated in the letters, according to the FDA.
In the meantime, the FDA encourages physicians to speak with patients who are using compound hormone therapy drugs about menopausal hormone therapy options and to report problems they encounter with compound hormone therapy drugs to the FDA.

Source: “FDA takes action against compounded hormone therapy drugs” 


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