FDA lifts black-box warnings on HRT for menopause

The FDA has removed what it calls “misleading’ warnings from human replacement therapy products for menopause. Women have used HRT products for decades for menopause symptoms, but their use sharply declined in the early 2000s when the agency began to apply warnings following a study that found a “statistically non-significant increase” in the risk of breast cancer. The FDA notes that studies show that women who begin hormone replacement therapy within a decade of the onset of menopause have a reduction in mortality and fractures. “The removal of the black-box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives,” said Alicia Jackson, director for the Advanced Research Projects Agency for Health.