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FDA takes action against compounded hormone therapy drugs
Discuss menopausal HT options with patients.
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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.
“With this new information, health care professionals will be able to better assess the risks and benefits of the different hormone therapy products available to treat menopausal symptoms,” Monroe said. “This information should also be helpful to a woman making a decision as to which menopausal therapy might be best for her.” – by Stacey L. Adams
This is very good news. It is nice to see the FDA is acting in situations where false advertising and claims to evidence are not substantiated and when potential for abuse can happen. Unfortunately, in some states two of three (patient, doctor and or pharmacist) can overturn a doctor-prescribed hormone regimen. Often, patients do not know the difference when substitution causes harm. Most of us have had the experience of trying to educate someone about consistency and differences, let alone cost when ‘bioidentical hormones’ are provided without endocrinologists’ knowledge or supervision. Each agent we use has risk/benefits/alternatives that we have to weigh each time we prescribe. This FDA action will make our tasks a little easier when we inform our patients of why the FDA acted. This is not to say that compound pharmacy under the direction of a knowledgeable physician is not useful either; it certainly is when adequate supervision and monitoring is available. As we update our patients about what is happening, it will help in our mission to have patients believe what we say and to continue with what we prescribe. It will make our task of adequate monitoring easier. Physicians and clinicians should be referred to credible organizations with excellent resources. These include easily accessible websites from leading organizations. Examples include North American Menopause Society, the Endocrine Society, the Association of Clinical Endocrinologist and the Office of Research on Women’s Health at the NIH, among others. There are now multiple FDA products approved for every indication. The list continues to grow in each area. Where a specific hormone is needed, compound pharmacy at the direction of the physician is available.
– Robert A. Wild, MD, PhD, MPH
Professor of Reproductive Endocrinology at Oklahoma University Health Sciences Center, Oklahoma City