Today the FDA announced it would begin asking drug companies to remove so-called black box warnings for hormones prescribed to treat symptoms of menopause.

The FDA says the warning has dissuaded generations of women from taking advantage of the medication that could help them.

Ali Rogan digs into the details.

That's right. Companies added this warning in the early 2000s, following a claim from researchers in a large women's health study that the drugs carried an increased risk of breast cancer. Many experts say that risk does not exist for many menopause hormone therapy candidates. To help explain today's announcement, I'm joined by FDA Commissioner, Dr. Marty McCarrie. Commissioner McCarrie, welcome back to the news hour.

Good to be with you. Thank you, Allie. Why is the FDA making these label changes?

Well, the fear machine that started 23 years ago with this tragic, misinterpreted study and the results

has resulted in a distorted perception of risk. And about 50 million women since that time have been

denied, never offered, or convinced out of hormone replacement therapy, including all of its

short-term and long-term benefits. And some of those benefits are profound, including reducing

the risk of cardiovascular disease and heart attacks.

That's the number one cause of death in women.

And no study subsequently has ever found, no clinical trial has ever shown that the risk of breast cancer mortality

is increased with hormone replacement therapy.

So women deserve all the facts facts and women's health issues have

historically not gotten the attention they deserve. In this administration, we are working hard

to make sure issues of women's health get the attention they deserve.

Now, in terms of the perception of risk, I want to break it down. There's two types of estrogen,

broadly speaking. There's local, which can be a cream.

It's applied directly to an area.

And then there's systemic, which takes the form of a pill or a patch and works its way through

the bloodstream.

This announcement today is going to apply to label changes for both.

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