S1: Welcome in San Diego. It's time for KPBS Midday Edition. On today's show , we hear about changes to the warning labels for estrogen therapy used to treat menopause symptoms. I'm Andrew Bowen in for Jade Hindman with conversations that keep you informed , inspired and make you think. Last week , the US Food and Drug Administration announced it would remove the black box warning labels on hormone therapy for menopause. These labels , which show up on medication packaging , warn of the risks of heart attack , breast cancer , stroke and blood clots. But the FDA says these risks are based on outdated science and that these black box warnings have long discouraged people from using hormones to treat their menopause symptoms. Now , the change is expected to come within the next six months. So what could that mean for menopause treatment going forward ? Midday edition host Jade Hindman spoke with Doctor Katherine McCauley earlier this week. She's a clinical professor and OB-GYN at UCSD health there. She's also the director of the Menopause Health Program. Here's that conversation.
S2: So these black box warning labels came from a study out of the Women's Health Initiative back in the early 2000.
S3: That was put in the black box warning , and they found that a certain fixed dose of conjugated equine estrogen or a certain type of estrogen with a version of progesterone , medroxyprogesterone acetate oral formulation. The combination increased the risk of blood clots like deep vein thrombosis , um , breast cancer , and resulted in an increased risk of heart attack and adverse cardiovascular outcomes. However , they had not yet published their data , stratifying the risk by age , so they just had the risk elevated. For all the women in the study , ages 50 to 79.
S2: So you mentioned equine estrogen , right ? So is that the only type of estrogen that's been researched or.
S3: No , no. There's um 17 beta estradiol. Um , there's um , different formulations as well. Transdermal formulations. So um , the problem we see with the black box warning from the , um , results from that initial study in 2002 is that it didn't take into account all the different versions of estrogen , progesterone and , um , formulations available. Interesting.
S2: Interesting.
S3: So unfortunately , women who were younger. It was later found out in 2007 when they did a a sub analysis of the initial study in the Stratifying Risk by Age. They found that actually there was not an increased cardiovascular disease risk or adverse outcome risk for women in the 50 to 59 year old age group. It was the older women who were at higher risk , those over 60 or more than ten years from menopause. So it's those women in the 50 to 59 year old age group that really , um , kind of got shortchanged , especially if they were having symptoms because the risk really weren't elevated.
S2:
S3: So for the most part , I have patients who feel very positively about it. And I see many women over the years , over and over again , having their lives very positively affected by using HRT or hormone therapy is actually what we call it h t um , these are women who were very symptomatic , though , and really have seen a benefit. So I think in that younger age group , within ten years of menopause , having a lot of symptoms , for most women the benefits outweigh the risk.
S2:
S3: Um , not really understanding the nuances between the different types of formulations , say the estradiol patch. Actually , observational studies show it doesn't increase the blood clot risk compared to oral estrogens. So some of these differences that that people didn't quite understand , even providers. So I think they were reluctant for that reason , um , as well. Yeah.
S2: Yeah.
S3: So there's a lot of talk out there about menopause , lots of women seeking out care. So I don't know what the plan is for warnings. Now at this point , um , what I would like to see is maybe warnings that are more formulation specific. Say , you know , that oral estrogen does come with a more warning about the increased risk of blood clots. But I would like to see yeah , maybe more , um , more specific warnings related to the product.
S2:
S3: Now , if if providers are thinking and patients thinking , well , there's no warning. It's safe for everybody. That's actually not true , as I was mentioning , because it's really the age and years since menopause that that weighs into the risk. So , um , the women who are older , I have had for the first time in years , women in their late 70s coming in asking if they could start on hormone therapy for the first time. And that's that's clearly not what we want to do. Um , we've learned from the what not to do. And that would be to start , women who are much older , particularly over over 70 , um , their risks are really the highest with starting for the first time. Yeah , without really much benefit given they're so far from menopause. Yeah.
S2: Yeah.
S3: We do need more research in the perimenopause women who are still having cycles. It's not some. Some will benefit from birth control pills to help control the symptoms. Some will benefit from using more traditional HRT , um or hormone therapy. But , um , it can be a little trickier just because women are still having cycles and hormone levels are fluctuating , but they can still potentially benefit from hormone therapy as well.
S2:
S3: There's a host of other symptoms that can go along with menopause as well. But the predominant indication and the best research we have in terms of type of symptoms that hormone therapy helps is vasomotor symptoms. So the hot flashes , night sweats if they're symptomatic. Um , they should certainly talk to their provider about what their treatment options are and consider hormone therapy.
S2: And you mentioned age earlier. What medical conditions might make hormone therapy risky.
S3: So a history of a blood clot for one. Um , that would need to be really investigated in terms of , you know , the circumstances or the context of of having a blood clot. Um , certainly one would want to avoid oral estrogen , in that case , a history of an estrogen sensitive cancer such as breast cancer and heart disease. History of a heart attack. History of a stroke. Those would be some some of the absolute contraindications. Or if a woman's having abnormal bleeding and it hasn't been investigated or evaluated , I wouldn't start hormones until that was investigated , particularly if having post-menopausal bleeding.
S2: You know , last time we spoke we talked about the state of menopause treatment in education.
S3: So I think a lot of , um , societies like the Menopause Society is improving their , um , certainly for their provider education , their number of certified menopause practitioners in the past two years , since 2003 has gone up more than 100% , as has their membership , so there's a lot more effort on their part to get people educated and making it accessible. Um , and I know for me , in our program at UCSD , we're just looking at expanding our education efforts for the students in residence.
S2:
S3: In the past , it was that , you know , hormones were too risky for women who were in their 50s symptomatic. Like I said , that some analysis of risk based on age from the W.H.O. was published in 2007. So that's years ago. We've known this information. This isn't really new information , but it's been misunderstood for years , just until now. Another misconception is that hormone therapy , I think there's on social media , there are people promoting using hormone therapy , you know , for. For everyone to use it forever. And that it's going to reduce the risk of dementia for one. But we don't really have the clinical trials that that conclusively tell us that hormone therapy reduces the risk of dementia. We have lots of promising research looking at the role of estrogen and cognition , and we're hopeful maybe that will be the case. But we don't really have that yet. As well as for heart disease , we don't really have long term clinical trials that answer the question , Will taking hormone therapy reduce my risk of heart disease ? But some encouraging studies that are just shorter term. So we're hopeful , again , that hormone therapy will show to be protective for the heart. But waiting for those trials one day maybe. Yeah.
S2: Yeah. Yeah. Well , you know , listen , being armed with knowledge is one of the best ways to support one could support themselves , rather going through menopause and in perimenopause.
S3: Menopause org. The Menopause Manifest Society has really improved their website and all their patient facing their patient facing website for consumer information and for providers as well. They're doing a great job with getting people educated up , you know , to , um , to make up for this education gap that we've had in menopause. They recently had a $10 million donation , and they're going to put some of that money , I believe , into education initiatives. So that's where I would direct patients to menopause.
S1: That was Doctor Catherine , the colleague , clinical professor , OB-GYN at UCSD health and director of the UCSD Menopause Health Program , speaking with Midday Edition host Jade Hindman. And that's our show for today. I'm your host , Andrew Bowen , in for Jade Hindman. Thanks for listening to Midday Edition. Have a great day.
