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Hormone-based drugs taken during menopause will no longer carry a bold warning label, the Food and Drug Administration announced this week. The so-called "black box" label that is being removed is the strongest warning for prescription drugs that the FDA can require. What they're saying: FDA Commissioner Marty Makary and some other doctors have long criticized the current warning for these drugs as outdated and unnecessary. 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. "We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts," Health Secretary Robert F. Kennedy Jr.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. Dig deeper: The 22-year-old FDA warning advised doctors that hormone therapy increases the risk of blood clots, heart problems and other health issues, citing data from an influential study published more than 20 years ago. Health officials with the FDA explained their change this week by pointing to studies suggesting hormone therapy has few risks when started before age 60 and within 10 years of menopause symptoms. Big picture view: The label warns about stroke, heart attack, dementia and other serious risks, and is being removed from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night sweats. Of note: The FDA sidestepped its usual public process in reviewing warnings when making this decision. Asked Monday why the FDA didn't convene a formal advisory panel on the issue, Makary said such meetings are "bureaucratic, long, often conflicted and very expensive." RELATED: Melatonin linked with higher heart failure rate in preliminary study Menopause hormone therapy The backstory: In the 1990s, more than 1 in 4 U.S. women took estrogen alone or in combination with progestin on the assumption that — in addition to treating menopause — it would reduce rates of heart disease, dementia and other issues. But a landmark study of more than 26,000 women challenged that idea, linking two different types of hormone pills to higher rates of stroke, blood clots, breast cancer and other serious risks. After the initial findings were published in 2002, prescriptions plummeted among women of all age groups, including younger menopausal women. Since then, all estrogen drugs have carried the FDA’s boxed warning — the most serious type.
