FDA HRT News

Posted by debbie1956 @debbie1956, 3 days ago

I thought some members might appreciate reading this Medscape article I just received regarding FDA proposal to remove black box warning on Menopause HRT: https://www.medscape.com/viewarticle/fda-panel-urges-review-boxed-warning-menopause-therapy-2025a1000swh?ecd=WNL_trdalrt_pos1_ous_251027_etid7828112&uac=360685MZ&impID=7

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

I feel the same. I am 68 and have been on BHRT for 16 months with nothing but positive benefits.

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Profile picture for janieben @janieben

Does anyone have a list of recent studies that actually prove women over 65 or 70 should not START bioidentical hormones due to increased risk of heart disease, stroke, dementia, etc.? I keep reading that some doctors are ok with prescribing for a 74 year old like me, and some doctors are totally against it. I would really like to see the evidence!

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@debbie1956 Thank you for your post. I read the study; I may be wrong, but I believe it focuses on women who are CONTINUING estrogen therapy past 65, not just starting it. I believe it also focuses on estrogen, not estradiol, and on oral rather than transdermal. This is the only line that actually commented on women over 65: "Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that." Most articles reference the WHI study, which uses oral estrogen, not transdermal estradiol, and progestogen rather than micronized progesterone. So...still looking for that article. 🙂 Thank you again for your sharing of your knowledge.

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Profile picture for janieben @janieben

@debbie1956 Thank you for your post. I read the study; I may be wrong, but I believe it focuses on women who are CONTINUING estrogen therapy past 65, not just starting it. I believe it also focuses on estrogen, not estradiol, and on oral rather than transdermal. This is the only line that actually commented on women over 65: "Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that." Most articles reference the WHI study, which uses oral estrogen, not transdermal estradiol, and progestogen rather than micronized progesterone. So...still looking for that article. 🙂 Thank you again for your sharing of your knowledge.

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@janieben I may have previously posted this podcast with Dr. Lauren Streicher you quoted from the Medscape article. My Menopause Society naturopath physician suggested Dr. Streicher's podcast when I began BHRT at age 67. She did the risk assessments mentioned by Dr. James Simon interviewed on the podcast: https://podcasts.apple.com/za/podcast/hormone-therapy-after-age-60-with-dr-james-simon/id1615785832?i=1000652082001

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Profile picture for findtheanswersdn @findtheanswersdn

@mayblin so does it mean that breast cancer and cardiovascular disease risks are lessened than in the past? And maybe those of us 69 yr post menopause with 15 years post can still be on low disease BHRT and lessened risks? I'm hoping will help my bones? IS that possible?

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@findtheanswersdn
For bones, estrogen mainly works by slowing bone loss, helping maintain bone density.

If interested, here is a link for FDA panel discussion:
https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025
From what I understand,

Breast cancer risk appears lower and more nuanced than older boxed warnings suggested, especially for estrogen-only therapy in women without a uterus. Unlike cardiovascular risk, breast cancer risk is more influenced by type and duration of therapy than by timing of initiation.

Cardiovascular risk depends largely on timing - lower if started before age 60 or within 10 years of menopause, and higher if started later. Transdermal estrogen tends to carry fewer cardiovascular and clotting risks than oral forms.

Starting HRT after age 60 or more than 10 years postmenopause carries higher cardiovascular and clotting risks, so cautious, individualized treatment favoring lower doses and transdermal routes is recommended.

The panel emphasized that formulation, route, and dose all influence breast cancer and cardiovascular risk, with transdermal and lower dose regimens generally safer.

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Profile picture for mayblin @mayblin

@findtheanswersdn
For bones, estrogen mainly works by slowing bone loss, helping maintain bone density.

If interested, here is a link for FDA panel discussion:
https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025
From what I understand,

Breast cancer risk appears lower and more nuanced than older boxed warnings suggested, especially for estrogen-only therapy in women without a uterus. Unlike cardiovascular risk, breast cancer risk is more influenced by type and duration of therapy than by timing of initiation.

Cardiovascular risk depends largely on timing - lower if started before age 60 or within 10 years of menopause, and higher if started later. Transdermal estrogen tends to carry fewer cardiovascular and clotting risks than oral forms.

Starting HRT after age 60 or more than 10 years postmenopause carries higher cardiovascular and clotting risks, so cautious, individualized treatment favoring lower doses and transdermal routes is recommended.

The panel emphasized that formulation, route, and dose all influence breast cancer and cardiovascular risk, with transdermal and lower dose regimens generally safer.

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From: "Mayo Clinic Connect" < nf+eafb360a+81757312@n1.hubapplication.com>
To: "acdcdolphin" < acdcdolphin@evertek.net>
Sent: Friday, October 31, 2025 10:00:46 AM
Subject: @mayblin mentioned you in comment on Mayo Clinic Connect

## reply above this line ##

THANK YOU FIR REPLYING. I WILL PONDER. HAVE A BLESSED DAY AND HAPPY HALLOWEEN. Do u live in Minnesota? I'm originally from okabena mn small sw town 400 people now living in pocahontas iowa small nw iowa town.
Mayo Clinic Connect
[ https://connect.mayoclinic.org/member/00-fc9271e24949da79367227/?utm_source=connect.mayoclinic.org&utm_medium=email&utm_campaign=mention&utm_content=mention_intro_userlink | @mayblin ] mentioned you in comment on Fri, Oct 31.

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@findtheanswersdn
For bones, estrogen mainly works by slowing bone loss, helping maintain bone density.

If interested, here is a link for FDA panel discussion:
https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025
From what I understand,

Breast cancer risk appears lower and more nuanced than older boxed warnings suggested, especially for estrogen-only therapy in women without a uterus. Unlike cardiovascular risk, breast cancer risk is more influenced by type and duration of therapy than by timing of initiation.

Cardiovascular risk depends largely on timing - lower if started before age 60 or within 10 years of menopause, and higher if started later. Transdermal estrogen tends to carry fewer cardiovascular and clotting risks than oral forms.

Starting HRT after age 60 or more than 10 years postmenopause carries higher cardiovascular and clotting risks, so cautious, individualized treatment favoring lower doses and transdermal routes is recommended.

The panel emphasized that formulation, route, and dose all influence breast cancer and cardiovascular risk, with transdermal and lower dose regimens generally safer.
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