In a significant development that could potentially stir controversy, Robert F.
Kennedy, Jr., the Secretary of Health and Human Services, announced on Monday that the Food and Drug Administration (FDA) will be lifting the "black box warning" from hormone replacement therapy (HRT) products.
These products are primarily used to treat low hormone levels in women undergoing menopause and post-menopause.
As reported by RedState, black box warnings are the most stringent warnings incorporated into the labels of prescription drugs or drug products by the FDA. These warnings are issued when there is reasonable evidence linking a serious hazard to the drug. The term "black box warning" is derived from the black box that surrounds the warning.
HRT products were first issued a black box warning in the early 2000s, following a study by the Womens Health Initiative. According to the FDA, the study found a "statistically non-significant increase in the risk of breast cancer diagnosis." This finding led to a significant drop in the use of HRT among menopausal women, resulting in countless women suffering from symptoms such as hot flashes and night sweats due to low estrogen levels.
Secretary Kennedy, addressing the issue of untreated menopause symptoms at a press conference held with FDA Commissioner Marty Makary, declared, "That ends today." He further stated, The era of ignoring womens health is over. Were challenging outdated thinking and recommitting to evidence-based medicine.
The FDA's shift in stance comes in the wake of identified flaws in the Women's Health Initiative study that led to the reduction of HRT prescriptions. The average age of women who participated in the study was 63, significantly older than the typical age for menopausal hormonal changes. Moreover, the hormone formulation taken by the women in the study is no longer commonly prescribed.
Upon conducting its own review of data, the FDA discovered that women who commenced hormone replacement therapy within ten years of menopause, and typically before the age of 60, experienced numerous benefits beyond symptom relief. According to the FDA, these additional benefits "include a reduced risk of all-cause mortality and fractures. HRT has also been associated with a 50% reduction in heart attack risk, a 64% reduction in cognitive decline, and a 35% lower risk of Alzheimers."
In essence, the government now contends that the benefits of HRT significantly outweigh the risks.
Kennedy stated, "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 added, "For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again."
FDA Commissioner Makary echoed these sentiments, saying, "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."
Also present at the announcement were Usha Vance, the Second Lady of the United States, and Lori Chavez-DeRemer, the Secretary of Labor.
The lifting of the black box warning from HRT products marks a significant shift in the government's approach to women's health, challenging long-held beliefs and potentially offering relief to millions of women suffering from menopause symptoms. This move underscores the importance of evidence-based medicine and the need to continually reassess medical practices in light of new research and data.
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