U.S. News
FDA Drops Harsh Warning Labels for Hormone Therapy
Clear Facts
- The FDA is removing “black box” warning labels from hormone replacement therapy products intended for menopause symptom relief.
- Decades of studies do not support original concerns about increased breast cancer risk from hormone therapy.
- Officials say the warnings discouraged many women from treatment despite evidence showing health benefits.
The FDA has announced it will take “black box” warnings off hormone replacement therapy medications used by menopausal women. The agency refers to new and long-standing evidence that does not support the heightened fears over cancer mortality rates tied to these treatments.
According to HHS Secretary Robert F. Kennedy Jr., these warnings were put in place to “frighten women and to silence doctors.”
“It warned of diseases and dangers that the data simply did not support. Bureaucrats at the FDA reacted out of fear, not gold standard science. And instead of correcting the record, the medical establishment doubled down in groupthink,” said Kennedy. “The consequences have been devastating.”
FDA Commissioner Dr. Marty Makary explained that data behind the initial black box warnings was “misrepresented and created a fear machine.” He argues more recent research shows the health benefits of hormone therapy outweigh suggested risks for most women, especially when started soon after menopause.
He wrote in an op-ed that HRT “alleviates the short-term symptoms of menopause, including hot flashes, night sweats, mood swings and weight gain, and when started within 10 years of menopause it has underappreciated long-term health benefits that even doctors may not be familiar with.”
Makary pointed to older studies, including a 1991 UC San Diego review showing HRT could reduce fatal coronary events by about 50%, and a 1996 University of Southern California report suggesting estrogen therapy might lower Alzheimer’s disease risk by 35%.
He noted the FDA’s current approach is about restoring trust in science and letting doctors work with their patients without fear-based rules.
Kelly Casperson, a urologist, said at the event that lifting the warning label would help “correct decades of misleading guidance.”
“The FDA’s decision to remove the box warning is not just regulatory,” she said. “It’s revolutionary.”
This major move signals a return to allowing Americans, alongside their doctors, to make informed health choices based on evidence, not bureaucracy.
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