Return to Transcripts main page

American Morning

Warning Labels Will be Required on Hormone Replacement Therapies

Aired January 09, 2003 - 08:44   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


PAULA ZAHN, CNN ANCHOR: The FDA is taking action that will affect millions of postmenopausal women. Warning labels will be required on hormone replacement therapies, in particularly any product containing estrogen.
Let's page Dr. Sanjay Gupta to find out why.

Boy, just when we thought we understand this subject, we get thrown another curveball. What is going on here?

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: I know. Well, I'll tell you, Paula, you and I have talked about this so many times. Certainly no effort to try to confuse people out there. I think this is actually a good thing because it's more information.

Paula, just some numbers, first of all. Six million women or so take some sort of hormone replacement therapy, and 40 percent to manage the symptoms of menopause, such as hot flashes. We have heard for a long time, Paula, as you alluded to, the women's health initiative was a study that basically showed that hormone replacement therapy, while it might effectively manage some of the symptoms of hot flashes, had some other pretty significant risks, when it came to breast cancer, when it came to heart disease, some of the very things that people originally thought hormone replacement therapy would treat.

With that information in mind, the FDA, as you mentioned, has decided to inform women even more so by actually putting warnings on some of the estrogen replacement therapies. Why a pharmaceutical already did this back in August of 2002, they put warning labels on, and now, the FDA has decided that all estrogen or estrogen progestin replacement therapies should have a sort of box warning on the product to basically alert the consumer to what they are getting themselves into.

What are those warnings going to say? Increased risk for heart disease, heart attacks, strokes, breast cancer, things we've talked about so many times. Here's an important one: not approved for heart disease prevention. When the trials originally started, people thought hormone replacement therapy might prevent heart disease. Not so. The warning will reflect that.

Take a look at the other warnings you will see on there. For women with significant risk of osteoporosis, prescribe this at the lowest dose as possible. If you still do need to take hormone replacement therapy to manage your symptoms of hot flashes, take the lowest doses, take it for the shortest duration. This is on effort, Paula, to try and arm the public with more information, something you and I have been trying to do since August of last year -- Paula.

ZAHN: Sanjay, you look at the list, and there is nothing on there i would seem to me that would make it compelling enough for someone to want to take unless they had desperate, desperate side effects of menopause. What would be the main benefits if you can establish the correct dosage?

GUPTA: Right. I think what you said at the end there is absolutely right. Some women have very profound, dramatic effects of menopause, and they have to make a decision, armed now with all of this information, as to whether or not they should take hormone replacement therapy, versus an alternative therapy, versus doing nothing.

Hormone replacement therapy does effectively manage some of the significant symptoms of menopause, such as hot flashes, such as sleep and mood disturbances, things like that.

So it's like anything else. Any other medication, you take, Paula, you have to sort of analyze the risks and benefits. Probably nothing is going to be risk-free, no medication. Is hormone replacement therapy worth the risk to try to manage what may be your profound symptoms of hot flashes? If so, then go ahead and take it.

Paula, keep these numbers in mind, the numbers you see on the screen here, estrogen, progestin therapy. What they found from this very large trial, increased invasive breast cancer up 26 percent, coronary heart disease, stroke, both up as well. There are other benefits as well. You can see colorectal cancer down 37 percent. You can take a look at the lists there, Paula. We just put up a bunch of risks and benefits. It's important for consumers to get as much information and make those, in this case, very tough decisions.

ZAHN: We always appreciate your help. Thanks, Dr. Sanjay Gupta.

GUPTA: Thanks, Paula.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com




Therapies>


Aired January 9, 2003 - 08:44   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
PAULA ZAHN, CNN ANCHOR: The FDA is taking action that will affect millions of postmenopausal women. Warning labels will be required on hormone replacement therapies, in particularly any product containing estrogen.
Let's page Dr. Sanjay Gupta to find out why.

Boy, just when we thought we understand this subject, we get thrown another curveball. What is going on here?

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: I know. Well, I'll tell you, Paula, you and I have talked about this so many times. Certainly no effort to try to confuse people out there. I think this is actually a good thing because it's more information.

Paula, just some numbers, first of all. Six million women or so take some sort of hormone replacement therapy, and 40 percent to manage the symptoms of menopause, such as hot flashes. We have heard for a long time, Paula, as you alluded to, the women's health initiative was a study that basically showed that hormone replacement therapy, while it might effectively manage some of the symptoms of hot flashes, had some other pretty significant risks, when it came to breast cancer, when it came to heart disease, some of the very things that people originally thought hormone replacement therapy would treat.

With that information in mind, the FDA, as you mentioned, has decided to inform women even more so by actually putting warnings on some of the estrogen replacement therapies. Why a pharmaceutical already did this back in August of 2002, they put warning labels on, and now, the FDA has decided that all estrogen or estrogen progestin replacement therapies should have a sort of box warning on the product to basically alert the consumer to what they are getting themselves into.

What are those warnings going to say? Increased risk for heart disease, heart attacks, strokes, breast cancer, things we've talked about so many times. Here's an important one: not approved for heart disease prevention. When the trials originally started, people thought hormone replacement therapy might prevent heart disease. Not so. The warning will reflect that.

Take a look at the other warnings you will see on there. For women with significant risk of osteoporosis, prescribe this at the lowest dose as possible. If you still do need to take hormone replacement therapy to manage your symptoms of hot flashes, take the lowest doses, take it for the shortest duration. This is on effort, Paula, to try and arm the public with more information, something you and I have been trying to do since August of last year -- Paula.

ZAHN: Sanjay, you look at the list, and there is nothing on there i would seem to me that would make it compelling enough for someone to want to take unless they had desperate, desperate side effects of menopause. What would be the main benefits if you can establish the correct dosage?

GUPTA: Right. I think what you said at the end there is absolutely right. Some women have very profound, dramatic effects of menopause, and they have to make a decision, armed now with all of this information, as to whether or not they should take hormone replacement therapy, versus an alternative therapy, versus doing nothing.

Hormone replacement therapy does effectively manage some of the significant symptoms of menopause, such as hot flashes, such as sleep and mood disturbances, things like that.

So it's like anything else. Any other medication, you take, Paula, you have to sort of analyze the risks and benefits. Probably nothing is going to be risk-free, no medication. Is hormone replacement therapy worth the risk to try to manage what may be your profound symptoms of hot flashes? If so, then go ahead and take it.

Paula, keep these numbers in mind, the numbers you see on the screen here, estrogen, progestin therapy. What they found from this very large trial, increased invasive breast cancer up 26 percent, coronary heart disease, stroke, both up as well. There are other benefits as well. You can see colorectal cancer down 37 percent. You can take a look at the lists there, Paula. We just put up a bunch of risks and benefits. It's important for consumers to get as much information and make those, in this case, very tough decisions.

ZAHN: We always appreciate your help. Thanks, Dr. Sanjay Gupta.

GUPTA: Thanks, Paula.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com




Therapies>