In a significant update announced on Monday in Jacksonville, Fla., the Food and Drug Administration (FDA) revealed its decision to eliminate the long-standing “black box” warnings from hormone replacement therapy (HRT) medications. These drugs, widely used by women to alleviate menopause symptoms, will no longer carry these prominent cautionary labels.

Robert F. Kennedy Jr., Secretary of Health and Human Services, confirmed this development, explaining that the former warning labels, which highlighted potential dangers like stroke, heart attack, dementia, and blood clots, are now deemed outdated and redundant.

“Today, the FDA is officially removing the misleading black box warnings from all HRT products,” Kennedy announced.

Medical professionals consider this change a significant victory for women across the nation.

Dr. Payal Kohli, a First Coast News medical consultant, explained the change reflects advances in science and an emphasis on personalized treatment.

“It really means it’s time to be thoughtful and personalize hormone replacement therapy for the women out there that need it,” Kohli said.

The FDA estimates millions of women avoided hormone therapy due to fear fueled by the black box warnings, with nearly a third citing the warnings as the main reason.

Kohli cautions that despite the removal of the warnings, hormone therapy should still be approached carefully.

“The reversal of this black box warning doesn’t mean that hormones should be taken willy-nilly,” she said. “Some of the changes they’ve made are still a little bit controversial, because there’s still some data suggesting potential for harm.”

An estimated 8 to 10 million women experience symptoms of menopause each year. Kohli emphasized that treatment should be personalized, rather than relying on broad warnings.

“Our approach to postmenopausal hormone replacement therapy has become much more personalized,” she said. “The same label applying to every single woman saying absolutely no because it causes cancer, it causes heart disease, and other risk factors is a little bit too elementary.”

She recommends women consult multiple specialists, starting with an OBGYN to determine the best treatment plan, a cardiologist to assess heart risks and an oncologist if there’s a history of cancer.

“I don’t want this to be the message, that every woman should stop menopause or turn the clock back on menopause and go and get on hormone replacement therapy,” Kohli said. “It may be reasonable to have a conversation with your doctor to assess your individual risk of getting on hormone replacement therapy versus not taking it.”