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FDA removes black box warnings on hormone therapy, opening access for women

The FDA is removing long-standing black box warnings from certain hormone therapy drugs—labels that health experts say have discouraged many women from seeking effective treatment for menopause symptoms. The decision aims to make hormone replacement therapy (HRT) more accessible for patients who could benefit from it.

Dr. Padma Kandadai, a Menopause Society Certified Practitioner at Boston Medical Center, joined Kerry Kavanaugh on Boston 25 News Now to explain what the change means. She noted that HRT is designed to treat symptoms caused by declining estrogen levels, such as hot flashes, night sweats and sleep disruption.

The FDA originally placed black box warnings on these medications due to concerns about risks highlighted in early studies, but updated research has provided a more nuanced understanding of who is an appropriate candidate.

Experts say increased awareness and access could be positive steps, but HRT should be used thoughtfully based on each patient’s health history and risk factors.

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