making medicine

Bioidentical Series: Who’s Making Your Medicine?

dailywellness Hormones, Women's Health

This is Part 2 of our 3 part series.

Seriously. Who is mixing up the stuff you swallow each day?

Previously in the series, we discussed the risks and benefits of bioidentical hormones. Today we talk to you about a topic rarely discussed between patients and doctors: who, exactly, is making your hormones?

It’s a particularly relevant question when it comes to bioidentical hormones, as we’ll explain in a moment. But first, let’s take a quick moment to review bioidentical hormones. What are they, again? From last week’s piece:

“…bioidentical hormones are no more or less “natural” than other forms of HRT. But, their molecules are shaped in such a way that makes them immediately recognizable by the body, because they have the same chemical and molecular structure as hormones that are produced in the human body.”

Bioidentical hormones are a popular option for women interested in hormone therapy, and you can read the breakdown of safety, effectiveness, and more in Part 1 of our series. Back to our original question though: who makes bioidentical hormones, and why is that fact so important?

COMPOUNDING PHARMACIES

Many bioidentical hormone products are manufactured by compounding pharmacies. Just how many, you ask?

“According to a new study, an estimated 28 million to 39 million prescriptions are filled each year for hormone-replacement therapies made by compounding pharmacies,” Arlene Weintraub in Forbes . “But two large Internet surveys reveal that a staggering 86% of women don’t understand that products sold by compounding pharmacies are not approved by the U.S. Food & Drug Administration.”

That’s right: compounding pharmacies are not approved, or regulated, by the U.S. Food & Drug Administration.

Now, you might be thinking: “heh. The FDA! How can I trust a big faceless institution like that, anyway?”

But here is what the FDA does do well: it provides critical oversight, as well as strict manufacturing regulations. In 2012, meningitis-contaminated steroid products were traced back to a compounding pharmacy in Massachusetts, and the results were devastating: 740 people were sickened by those drugs, 64 of whom died . Had this compounding pharmacy been subjected to the rigor the FDA demands for manufacturing quality, there is a good chance this tragedy could have been avoided.

WHAT IS A “COMPOUNDING PHARMACY?”

Compounding pharmacies combine or process ingredients using various tools to alter or manufacture pharmaceuticals: say, to change a solid pill to a liquid, or to extract a non-essential ingredient that a patient is allergic too. And, to be fair, compounding pharmacies are licensed and regulated by their respective states, just like all other pharmacies. National standards have also been created by Pharmacy Compounding Accreditation Board (PCAB). But: accreditation is not mandatory, and inspections for compliance occur only every three years. Years!

It’s normal to be a little concerned at this point. But, the 2012 incident in Massachusetts is what prompted the passage of the Drug Quality and Security Act , so suffice it to say that contamination risk for drugs is now lowered. However, compounding pharmacies are still not FDA-approved, which is why hormone levels in their products can’t always be trusted.

IS THERE A RISK TO GETTING BIOIDENTICAL HORMONES FROM COMPOUNDING PHARMACIES?

So, about those hormone levels…

In 2012, More magazine, with partial funding from the Fund for Investigative Journalism, set out to test hormone levels in bioidentical hormones produced by 12 compounding pharmacies nationwide. And let’s just say the results were pretty interesting. As Phyllis Greenberger reports,

“it was revealed that these hormones were of unreliable potency, and that they would not come close to meeting the FDA’s requirements for commercially manufactured drugs. In fact, the doses in the pills tested fluctuated in a way that could increase the risk of uterine cancer. ”

Which is pretty shocking, huh? And affirms the thing the FDA does right: it controls for safety, with their tough regulations.

We are still in the very early stages of relying on compounding pharmacies, and as the industry matures, so too will the safety requirements. But if you are a woman considering the use of bioidentical hormones, it’s critical to know the manufacturing source. Some compounding pharmacies have volunteered for more stringent oversight by the FDA’s regulations, which isn’t the same thing as being FDA approved – but, it’s a significant step in transparency and patient safety.

ARE THERE ALTERNATIVES TO BIOIDENTICAL HORMONES?

It’s no wonder women are confused, and often find themselves at a loss for answers when it comes to HRT: bioidentical hormones became trendy in response to the Women’s Health Initiative study (which we discussed in Part 1 of our series), which showed increased risk of breast cancer for postmenopausal women taking FDA-approved hormones Premarin and Prempro, which derive hormones from horses. So if you’re concerned about that study, but also concerned about compounding pharmacies…what are you supposed to do?

Asensia® is a natural supplement designed to raise progesterone levels to what’s normal for a younger woman, by helping the body make more of it on its own. And, a large part of its efficacy has to do with the quality of raw ingredients sourced to make this supplement. As you probably already know, all supplements are not created equally, and poor quality raw materials are the reason so many people see little difference (or worse, side effects) with their health when taking them. Finding the most potent, vigorously tested raw ingredients has always been a core value for Daily Wellness Company, which is why users are often pleasantly surprised at how quickly and powerfully Asensia works. Quality matters.

For more information on Asensia® and how it can address progesterone levels, visit our FAQ page. To read clinical studies and research devoted to our formula, visit our Clinical Studies page.

 

ADDITIONAL LINKS + RESOURCES:

https://my.clevelandclinic.org/health/articles/bioidentical-hormones

https://www.forbes.com/sites/arleneweintraub/2015/02/20/women-fooled-by-untested-hormones-from-compounding-pharmacies/#5e232501783c

https://imcwc.com/html5-blank/compounding-pharmacies-and-bioidentical-hormones/

https://www.medscape.com/viewarticle/842531

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4819678/

http://www.pharmacist.com/article/compounded-bioidentical-hormone-therapy-does-regulatory-double-standard-harm-women

http://www.wbur.org/commonhealth/2016/09/23/hormone-therapy-concerns

https://journals.lww.com/menopausejournal/Citation/2015/09000/Compounded_bioidentical_hormone_therapy__.4.aspx

http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html?_r=0

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