FDA to remove warning label from hormone-based menopause drugs

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.

- By MATTHEW PERRONE

EVAN VUCCI Associated Press FDA Commissioner Marty Makary said the longstanding warning label is outdated and unnecessary.

U.S. health officials said they will remove the boxed warning from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms such as night sweats.

The change has been supported by some doctors — including FDA Commissioner Marty Makary, who has called the current label outdated and unnecessary.

Health officials explained the move by pointing to studies suggesting hormone therapy has few risks when started before age 60 or within 10 years of menopause symptoms.

“We're challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said in introducing the update.

The 22-year-old FDA warning advised doctors that hormone therapy can increase the risk of blood clots, heart problems and other health issues, citing data published more than 20 years ago.

Many doctors — and pharmaceutical companies — have called for removing or revising the label, which they say discourages prescriptions and scares off women who could benefit.

Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the warnings have created a lot of hesitancy among patients.

“I can spend 30 minutes counseling someone about hormone-replacement therapy — tell them everything — but when they fill the prescription and see that warning they just get scared,” Fleischman said.

Other experts have opposed making changes to the label without a careful, transparent process.