menopause hormones warning FDA drugs pills women.

FDA Commissioner Martin Makary speaks during an event about drug prices with President Donald Trump, Thursday, Nov. 6, 2025, in the Oval Office of the White House in Washington. (AP Photo/Evan Vucci)

FDA will remove long-standing warning from hormone-based menopause drugs, citing benefits for women

The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause symptoms in women. The change announced Monday is a break from more than 20 years of FDA policy, in which the drugs carried the agency’s most severe warning label. But FDA Commissioner Marty Makary and some other doctors have long criticized the current warning label as outdated and unnecessary. They say it discourages some women from seeking treatment that can help with hot flashes, vaginal dryness and other uncomfortable symptoms. Other experts have said the warning carries important information about risks of stroke, heart attack and breast cancer.

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