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You’ve likely seen in the news or on social media this week that the FDA has removed the black box warning on estrogen products used for treatment of menopause related symptoms. But, you may be confused on what that is, what it means for you, and what to do now.

In this blog, I’m breaking it all down for you. Let’s get into it!

Black Box Warnings:

what is a black box warning?

A black box warning is the highest level or warning to alert doctors, patients and pharmacists that a medication has serious risks. Every medication has a pamphlet outlining risks, side effects or precautions, but the black box warning is intended to alert that there are more possible serious risks and they should be weighed against the benefit of the medication.

The black box warning is currently on all estrogen-related products including vaginal, topical and systemic estrogen for menopause.

what are the risks?

The black box warning on estrogen products for menopause warns for risks of cardiovascular disease, clot/stroke, breast cancer, and dementia.

This is for all estrogens: vaginal, topical, oral, synthetic without any comment on age or menopause status.

why was the black box label removed?

There has been a push for a long time to remove this label on vaginal estrogen products. Vaginal estrogen comes with almost no risks and the research is very confident that it doesn’t increase risks of these diseases.

The absorption of estrogen vaginally is local and doesn’t increase blood levels of estrogen in a significant enough way to cause these risks. Many in their menopause journey WILL benefit from vaginal estrogen and so we’re happy to decrease fear over this product.

What about topical estrogen?

The removal of this warning for topical estrogen products also makes sense! While there are still risks of topical estrogen, for many women (particularly those <60years old and within 10 years post menopause), these risks aren’t often serious or large.

The pamphlet will still articulate the risks, but they will no longer be black box warnings.

What does this mean for canada?

Nothing yet, as the FDA is an American regulatory body. Health Canada will need to make their own decisions and changes, but hopefully this is facilitate and accelerate the process in Canada. \

Is This A Positive Thing?

Yes. Vaginal estrogen is incredibly low risk and the black box is NOT accurate for vaginal use, so this is great!

BUT… Topical (non vaginal) estrogen still comes with risks. For many women, the benefit outweighs the risks, but we still need to have risk/benefit discussions.

And news report claims of HRT preventing dementia and preventing cardiovascular disease were overblown. We don’t think that’s true for the average woman. And it some it may increase risks.

The conversation is nuanced and needs to be a conversation! The answer for you will not be the answer for your friend, and your answer may change as other health concerns come and go. So, it’s always important to seek support from your trusted health team.

I hoped this helped answer some questions you have about the recent events revolving around the removal of the black box warning with estrogen

Please feel free to reach out with any questions, as this conversation is very nuanced.

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Disclaimer:

This content is for informational and educational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician, naturopathic doctor, or other qualified healthcare provider with any questions you may have regarding a medical condition or health concern. Never disregard professional medical advice or delay seeking it because of something you have read here.