Are compounded bioidentical hormones safe?

Marina Johnson
Endocrinology Diabetes & Metabolism

As a hormone specialist who’s a board-certified endocrinologist and pharmacist, I can attest to the value of compounded products. However, if I have a choice of a compounded or pharmaceutical bioidentical hormone product, I will always prescribe the pharmaceutical product because they have to meet stricter standards of quality control, and provide more consistent results. Even though they contain identical ingredients, the FDA does not regulate compounded products. Without the warning labels, women mistakenly assume there are no risks. Compounded hormone replacement therapy ((HRT) carries the same risks as pharmaceutical bioidentical hormones

Compounding pharmacists play an important role in providing products for patients with allergies and other special needs. They can also compound products that are not commercially available. Pharmaceutical companies sometimes withdraw drugs from the market not because of poor efficacy but because there may not be enough market demand for their product. . If a physician chooses to prescribe compounded hormones, patients should be monitored in the same manner as any other patient receiving HR. 

Read more in my guidebook for women, “Outliving Your Ovaries:  An Endocrinologists Reviews and Risks and Rewards of Treating Menopause with Hormone Replacement.”

Since compounded bioidentical hormone alternatives to U.S. Food and Drug Administration (FDA)-approved estrogen and progestogen formulations have the same active ingredient, they obviously are going to have the same benefits, and the same safety concerns. But unlike commercial hormones, the distributors and promoters of compounded hormones deny these risks. And that's really misleading. So, how do they get away with it?

Since the FDA does not regulate compounding pharmacies, they can make whatever claims they want. So, they tell women what they want to hear -- namely that compounded bioidentical hormones have fewer risks, fewer side effects, and are more effective than standard hormones even though there is no scientific evidence to prove that claim.

While women generally distrust the pharmaceutical industry -- which is legally obligated to back up their claims, does testing, and reports all safety risks and negative findings -- the general population seems to have little problem placing their trust in companies that have no such efficacy or safety standards. This combined with aggressive advertising and marketing has resulted in women believing that compounded products are safer than standard products.

It's pretty scary to think that millions of women are using prescription drugs that have never gone through a new drug approval process to substantiate safety, prove efficacy, and ensure quality.

Since it is the same active ingredient, what's the problem?

It's the dosages and protocols, which are commonly recommended, that have never been shown to be safe, much less safer or more effective than conventional prescription estrogen products. Transdermal progestogens from a compounding pharmacy are potentially dangerous since there is no evidence that they prevent the lining of the uterus from developing pre-cancerous or cancerous cells. Only oral progestogens have been proven to offer that protection.

Continue Learning about Endocrine System

Endocrine System

Your endocrine system works with your nervous system to control important bodily functions. The endocrine systems responsibilities include regulating growth, sexual development and function, metabolism and mood. The endocrine syst...

em also helps give your body the energy it needs to function properly. Endocrine glands secrete hormones into the bloodstream. Hormones are considered chemical messengers, coordinating your body by transferring information from one set of cells to another. Your endocrine system health can be affected by hormone imbalances resulting from impaired glands. A hormone imbalance can cause problems with bodily growth, sexual development, metabolism and other bodily functions. Endocrine system diseases or conditions include diabetes, growth disorders and osteoporosis.

Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.