FDA Removes Black Box Warning on Hormone Therapy

TIME

Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food and Drug Administration announced Monday.

Transcript

00:00The FDA is initiating the removal of a broad black box warnings from hormone replacement

00:07therapy products for menopause. We're challenging outdated thinking and recommitting to evidence-based

00:16medicine that empowers rather than restricts. For the past over 20 years, there's been a black

00:22box warning on all hormone therapy products, including products containing estrogen and

00:28progesterone. And this has led many providers and women to avoid using the products. And so this is

00:38really quite amazing. I think the concern with the black box warning was that it was using data from

00:44the Women's Health Initiative study from 2002, which used a fixed dose of one particular estrogen and

00:50progesterone product. And it cites all the risks from that study, but doesn't reflect some of the

00:58differences between different hormone therapy preparations that may be safer. The black box

01:02warning didn't reflect some of the nuances about prescribing hormones and the different preparations

01:07available. So that's why it's exciting to have it taken off the labeling because not all the risks

01:16are the same, depending on what type of hormone you use. There will still be a label in place for

01:21endometrial cancer for using unopposed estrogen without progesterone. If in a woman who has a

01:26uterus, that will increase the risk of endometrial cancer. So that warning appropriately will still

01:30be there. So what we know today is that a symptomatic woman who's, again, I've said this

01:36over and over again, but I think this is the important part that who's earlier in the menopause

01:40transition within 10 years under the age of 60, who is symptomatic and doesn't have any contraindications

01:45to using hormone therapy, that majority of women can safely use hormone therapy. We've learned a lot

01:50in the last 20 years since the WHI. And so we don't want to just limit hormone therapy into a black box,

02:00basically. It really, it's been freed from that now. And I think women will feel more comfortable

02:06using the product and providers will be more comfortable prescribing it because that's been

02:10a big barrier as well in the last 20 years is women getting, being able to get prescriptions for the

02:15products, even if they did want it.

Category

Transcript

Be the first to comment

Recommended