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Women, healthcare providers celebrate removal of "black box warning" from hormone replacement therapy options

The FDA's recent change of course on certain hormone therapies during menopause is welcome news for many women and their healthcare providers.

Last month, the agency removed the "black box warning" from most hormone replacement products.

Experts say the original warnings from more than 20 years ago were based on outdated information and were "overly broad."

"I think the fantastic part about this FDA announcement is that my daughters will not have their mother's menopause," said Karen Dennis.  

Dennis is technically in post-menopause now. She went through the change almost 20 years ago.

"I was having a lot of the symptoms that are associated with menopause, but really nobody talked about it. It wasn't a conversation that women my age were having," she said.

Back then, she was advised against hormone replacement therapy because her own mother had had breast cancer.

At the time, a study called the "Women's Health Initiative" suggested a possible increase in breast cancer risk for women taking HRT.

Experts applaud updated guidance on HRT

The FDA now says that the study is outdated and is removing a decades-old black box warning from certain hormone therapies.

"I feel like that decade of my life from 50 to 60 was associated with night sweats and moodiness and losing my hair and all the things that are associated with menopause, and I didn't have the benefits of HRT," Dennis said. "Which, besides helping you with the symptoms of menopause, is good for your heart. And it's good for your bones, and it's good for your hair, and it's good for your skin. So I missed out on all those benefits."

Dr. Armando Hernandez-Rey is a reproductive endocrinologist in Coral Gables.

"People think that it was a bad study, but it was actually a very good study. The problem is that the information that was released was interpreted incorrectly," he explained.

He said he was "overjoyed" at the news of the removal of the black box warning.

"This is something that women have been begging for some sort of relief in whatever form that it came," he said. "What we are doing is replacing what the ovary has no longer been able to do, like it's done for the last 40 years. The same way we replace men on testosterone therapy, because as men age, they're not producing the same amounts of testosterone."

Hernandez-Rey says there's never been a similar warning on testosterone replacement therapies for men.

While Dennis is past that stage, she's hopeful other women will have more treatment options.

 "That makes me feel very optimistic," she said. "That's a very helpful thing for you to know that your children will not have to experience what you had to experience because of a misinterpretation of the study."

 The FDA will now provide new age-specific guidance on product labels.

But, as always, you should still discuss the risks and benefits with your healthcare provider to determine if HRT is right for you.

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