Latest / Empower Your Menopause / Episode 69 Special Update: FDA Removing Black Box warnings from HRT in the US

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Episode 69 Special Update: FDA Removing Black Box warnings from HRT in the US · Empower Your Menopause

• 0:13
  SPEAKER_01: Hello and welcome back to Empower Your Men and Pause, the podcast about health, happiness and hormones for women 40 and above.
• 0:20
  SPEAKER_01: It's coaches James and Julie here, and we're glad to have you back with us again.
• 0:24
  SPEAKER_01: So today we're just jumping in for a special episode for you to talk about an important announcement that's been made this week in the USA where the FDA, that's the Federal Drugs Administration, is removing some scary black box warnings on menopause hormone therapy.
• 0:40
  SPEAKER_01: So we talked about this a couple of weeks ago on our Hot Flushes and Hot Topics podcast.
• 0:46
  SPEAKER_01: Um but Julie, you've been following this quite closely.
• 0:49
  SPEAKER_01: So let's go over it again.
• 0:52
  SPEAKER_01: In context, what's happened and what does the announcement mean?
• 0:59
  SPEAKER_00: Yeah, sure.
• 1:00
  SPEAKER_00: It's very exciting actually.
• 1:01
  SPEAKER_00: So FDA Commissioner Dr.
• 1:04
  SPEAKER_00: Marty Macari, or Monakari, sorry if I'm mispronouncing, on Monday, um, which was yesterday, we're recording today, on Tuesday, November 11th, um, the agency, the FDA, is working to remove language on the product labels, referencing risks of heart disease, breast cancer, dementia, and those things to encourage greater HRT use among menopausal women.
• 1:26
  SPEAKER_00: Because the agency believes that the benefits of lower heart attack risk, reduction in cognitive decline, and lower Alzheimer's disease risk outweigh the potential harms.
• 1:38
  SPEAKER_00: So the labels are still going to include the risks, but just not in this boxed maximum alarm, we're all gonna die kind of format, as they have done for so many years.
• 1:48
  SPEAKER_01: Yeah, so thank you.
• 1:49
  SPEAKER_01: So put that in context then.
• 1:52
  SPEAKER_01: Give us a little bit of the history behind it, and why is this so important for women over in the US?
• 2:00
  SPEAKER_00: Yeah, it's it's interesting because there was a study called the Women's Health Initiative done some years ago, and their early interpretations of their studies have now been superseded by newer evidence that shows the risk of hormone replacement therapy or menopause hormotherapy.
• 2:20
  SPEAKER_00: It really depends on a lot of other factors that weren't taken into account then, like age, the timing, the type of HRT, and the route, because there are many different forms of HRT to use.
• 2:34
  SPEAKER_00: The women's health or WHI study enrolled older women many years past menopause, so it was it was much less applicable to the early start users and women in paramenopause and this this part of the transition.
• 2:50
  SPEAKER_00: So timing really matters.
• 2:52
  SPEAKER_00: There's a window of opportunity here.
• 2:54
  SPEAKER_00: So the FDA is citing updated evidence and expert review because the general aim really is just to undo all of this fear-driven underuse and enable personalized care.
• 3:08
  SPEAKER_00: And that's the key here is personalized care, like everything in menopause, it needs to be tailored to each individual woman going through it.
• 3:17
  SPEAKER_00: And women's health underrepresentation is finally getting some attention, which is really exciting.
• 3:23
  SPEAKER_00: As a matter of fact, part of that announcement was about how how much that's been neglected in in the years past with medical research.
• 3:33
  SPEAKER_00: So the challenge with the old warnings before was that when they were added, it reduced HRT use by around 50%.
• 3:41
  SPEAKER_00: And that's really significant when you look at the many benefits it does have for so many women.
• 3:47
  SPEAKER_01: Yeah.
• 3:48
  SPEAKER_01: So we're taking the warnings off the boxes, and this is again US products, right?
• 3:54
  SPEAKER_01: Uh, it's not applicable to the UK, but there are still some warnings there, there's still labels there, and that's fine print.
• 4:00
  SPEAKER_01: So, what is a fine print now saying?
• 4:03
  SPEAKER_01: And and what does why does that matter?
• 4:08
  SPEAKER_00: Well, it it matters.
• 4:09
  SPEAKER_00: So things like you know, if you still have a uterus and you're taking systemic estrogen, you definitely need to take progesterone to protect the endometrium.
• 4:20
  SPEAKER_00: That's um endometrial hyperplasia and cancer risk remains a known issue with this.
• 4:26
  SPEAKER_00: So the warning is going to still stay in the text.
• 4:30
  SPEAKER_00: There are a lot of other risks that aren't going to be erased, but they're going to be contextualized, right?
• 4:36
  SPEAKER_00: So stroke risk varies by root and dose, breast cancer risk, um, that relates more to combined therapy and duration.
• 4:46
  SPEAKER_00: Absolute risks are still small in healthy newly menopausal women.
• 4:51
  SPEAKER_01: Okay, great.
• 4:52
  SPEAKER_01: So let's quickly bust a few myths before we sign off then because I think we've covered this nice and comprehensively and relatively quickly.
• 5:00
  SPEAKER_01: So I'm going to fire some myths at you, Julie.
• 5:02
  SPEAKER_01: You give me your answer.
• 5:03
  SPEAKER_01: Myth number one, HRT or MHT is dangerous for everyone.
• 5:08
  SPEAKER_00: Yeah, really not.
• 5:09
  SPEAKER_00: For healthy women starting within 10 years of menopause or before the age of 60, benefits usually and often outweigh the risks.
• 5:17
  SPEAKER_00: Your risk profile is going to change with your age and your health status.
• 5:22
  SPEAKER_01: Yeah.
• 5:22
  SPEAKER_01: Okay, all HRT stroke, MHT is the same.
• 5:27
  SPEAKER_01: Next mix.
• 5:28
  SPEAKER_00: Right.
• 5:28
  SPEAKER_00: So yeah, big myth.
• 5:30
  SPEAKER_00: The type of HRT, so is it estrogen alone?
• 5:34
  SPEAKER_00: Is it combined?
• 5:35
  SPEAKER_00: The strength of the dose, the root.
• 5:38
  SPEAKER_00: So are you taking it in a patch or a gel versus an oral administration or local versus systemic also makes a big difference.
• 5:47
  SPEAKER_01: Okay.
• 5:48
  SPEAKER_01: Okay, so next myth: vaginal estrogen has the same systemic risks.
• 5:54
  SPEAKER_00: This is really important to understand.
• 5:57
  SPEAKER_00: Low-dose local therapies like vaginal um estrogen have minimal systemic absorption and they were very unfairly stigmatized.
• 6:06
  SPEAKER_00: As a matter of fact, women who often can't take estrogen for other reason, these extra low doses introduced vaginally can often be okay for them as well.
• 6:19
  SPEAKER_01: Excellent.
• 6:19
  SPEAKER_01: So let's start to wrap up then.
• 6:22
  SPEAKER_01: So here's a take-home for everybody.
• 6:24
  SPEAKER_01: So the box is going and nuance is back, I guess.
• 6:30
  SPEAKER_01: MHT stroke HRT isn't a cure all, but for the right women, it can be absolutely life-changing.
• 6:36
  SPEAKER_01: We've advocates of the fact that it's your body and it's your choice, and you need to make that choice with good evidence and clinicians who actually listen.
• 6:45
  SPEAKER_01: So we're broadly pro-HRT on this podcast and within the work we do at Fabulous Beyond 40.
• 6:52
  SPEAKER_01: We appreciate it's not for everyone, and so we advocate for pro-informed consent for you as women who might want to take these products.
• 7:03
  SPEAKER_01: So, just before we go, then final thing if this has been helpful or you know someone who needs to hear this news and have an idea of what's going on and be better informed, please like and share this episode.
• 7:17
  SPEAKER_01: In the meantime, we've been Julian James from Fabulous Beyond 40.
• 7:20
  SPEAKER_01: We'll be back with a normal podcast later in the week.
• 7:23
  SPEAKER_01: But in the meantime, stay strong, stay fabulous, and we will see you next time.
• 7:28
  SPEAKER_01: Take care.