Politics

U.S. FDA to Remove 'Black Box' Warnings from Menopause Hormone Therapies

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Nov 10, 2025

THE BARE STORY

The U.S. Food and Drug Administration (FDA) announced on Monday it is removing its "black box" warnings from many hormone therapy medications used to treat symptoms of menopause and perimenopause. These alerts, which represent the agency's most serious type of safety warning, had been in place on the treatments for several decades. The policy change affects medicines containing estrogen and progesterone, as well as other systemic and topical estrogen products.

In an interview, FDA Commissioner Dr. Marty Makary described the previous warnings as an "American tragedy." He stated that the labels were based on what he said many experts now consider flawed research from a 2002 study that overstated certain health risks. According to Dr. Makary, more recent studies suggest that for many women, the benefits of hormone therapy outweigh the risks if treatment begins in the early years of menopause and before the age of 60.

Dr. Makary asserted that hormone therapy can reduce the risk of conditions such as heart attacks, osteoporosis, and cognitive decline, and claimed that no clinical trial has ever shown it increases a woman's risk of dying from breast cancer. He further stated that "dogma" following the 2002 study led to 50 to 70 million women being denied the therapy's benefits.

The commissioner advised that hormone therapy is best started within 10 years of menopause onset and is not suitable for everyone, especially women with a history of breast cancer. For those individuals, he noted that the FDA has approved non-hormonal options. Separately, Dr. Rachel Rubin, a urologist, stated that the now-removed warning labels had led to "decades of misinterpretation."

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• The treatments previously carried the FDA's most serious safety alert. For several decades, these hormone therapies were labeled with "black box" warnings. The article notes that this type of alert represents the most serious safety warning issued by the agency, indicating that the potential risks were previously considered highly significant.

• The therapy is not suitable for everyone and carries known risks for some patients. The FDA Commissioner specifically advised that the treatment is not appropriate for all individuals. He highlighted that it is not suitable for women with a history of breast cancer, for whom the FDA has approved non-hormonal options instead.

• The therapy's safety profile is dependent on specific timing. The article clarifies that the benefits of hormone therapy are believed to outweigh the risks primarily under certain conditions. Treatment should ideally start within 10 years of menopause onset and before the patient is 60 years old, suggesting that the timing is a critical factor in its safe use.

How it may affect me

As a U.S. reader:

• Women experiencing menopause may have greater access to hormone therapies, as the FDA's most serious safety warnings are being removed from many of these medications.

• Patients will need to consult with doctors about timing, as the therapy's benefits are linked to starting treatment within 10 years of menopause and before age 60.

• The change could lead to better health outcomes for some, as the FDA states the therapy may reduce risks of heart attack, osteoporosis, and cognitive decline.

• Individuals with a history of breast cancer will not be candidates for this therapy and will continue to rely on approved non-hormonal treatment options.

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