❓WHAT HAPPENED: The U.S. Food and Drug Administration (FDA) announced the removal of “black box” warnings from over 20 hormone replacement therapy products used for menopause symptoms.
👤WHO WAS INVOLVED: Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, and the American College of Obstetricians & Gynecologists.
📍WHEN & WHERE: The announcement was made Monday, with updates to drug labels now underway in the United States.
💬KEY QUOTE: “We are returning to evidence-based medicine and giving women control over their health again.” – Robert F. Kennedy Jr.
🎯IMPACT: Women seeking hormone replacement therapy will have more informed choices, with updated labels reflecting a nuanced understanding of risks and benefits.
The U.S. Food and Drug Administration (FDA) announced it would remove “black box” warnings from over 20 hormone replacement therapy (HRT) products used to treat menopause symptoms, such as hot flashes and bone loss. The warnings previously highlighted risks of cardiovascular disease, breast cancer, and probable dementia. They will remain on products with a risk of endometrial cancer for systemic estrogen-alone treatments.
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. emphasized the importance of the decision, stating, “Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment.” He criticized the outdated warnings as a result of “bad science and bureaucratic inertia” and praised the move as a return to evidence-based medicine.
The FDA’s decision followed an expert literature review conducted in July, which concluded that the risks of HRT had been overstated for women in their fifties. The agency also announced the approval of two new drugs, including a generic version of Premarin and a non-hormonal medication for treating menopausal symptoms.
FDA Commissioner Marty Makary noted that the warnings had deterred many women from seeking treatment. “Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” he said.
The American College of Obstetricians & Gynecologists welcomed the updated labels, with its president, Dr. Steven J. Fleischman, stating, “The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms.” He also cautioned that systemic estrogen products still carry different risks compared to low-dose vaginal estrogen.
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