US EditionINTERVIEW: FDA Removes Warning Labels on Menopause Hormone Therapy
The FDA removed the 2003 black box warning from systemic and localized menopausal hormone therapies after reassessing their safety and effectiveness.
- The FDA reversed a 2003 decision and removed the black box warning from menopausal hormone therapy products, including systemic and localized forms, while asking drugmakers to update labels on cardiovascular, cancer, and dementia risks.
- The 2003 Women’s Health Initiative study prompted adding a black box warning after linking oral estrogen and synthetic progestin to higher risks, while today doctors favor transdermal estrogen patch and natural progesterones.
- The agency requested that drug companies that manufacture MHT products submit new, literature-supported label language, and expert advisory panel recommendations led to label reprints reflecting benefits and risks by age and menopause timing.
- Clinicians caution that removing the black box warning may lead menopausal women considering hormone therapy to reconsider, but experts warn treatments are not risk-free and advise healthcare providers to promote shared decision-making.
- Debate continues over whether removal of the black box should apply uniformly to all MHT forms as the American College of Obstetricians and Gynecologists keeps its guidelines unchanged, noting vaginal/local estrogen products have minimal absorption while oral estrogen and transdermal patch forms pose different risks.
32 Articles
32 Articles
After 20 years, the U.S. agency FDA removes the strictest warning for hormone replacement therapies. What is behind this change of heart?
US health leaders hailed the benefits of hormone therapy for menopause. Doctors are pushing for balance
Experts say FDA officials and doctors should treat hormone therapy like any other drug that has both benefits and risks, and remember that hormones aren’t the only options for treating menopausal symptoms anymore.
Watauga Democrat
FDA Lifts Major Warnings on Hormone Replacement Therapy
Key Takeaways
FDA Removes Black Box Warning on Hormone Therapy
U.S. health officials have announced the first steps to remove the black box warning on estrogen products prescribed to treat symptoms of menopause. The warning was added to the products in 2003 when data from a large government study on women’s health, known as the Women’s Health initiative (WHI), showed that the hormone therapy was linked to an increased risk of a number of conditions, including breast cancer, heart disease, blood clots, and p…
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