Hormone-based therapies commonly used to alleviate symptoms of menopause, such as hot flashes and night sweats, are set to undergo significant changes in their labeling, according to an announcement from the Food and Drug Administration (FDA) on Monday. The agency revealed it will remove the bold warning label that has highlighted serious risks including stroke, heart attack, and dementia associated with these treatments.
The FDA’s decision affects over 20 hormone therapies, including pills, patches, and creams that utilize estrogen and progestin. Officials, including FDA Commissioner Marty Makary, indicated that the outdated warning created unnecessary fear around these medications, potentially discouraging women from seeking effective relief. In support of the change, the FDA published a commentary in the Journal of the American Medical Association, advocating for a more evidence-based understanding of hormone therapy risks.
FDA officials noted that recent studies suggest the safety profile of hormone therapy is considerably better when treatment begins prior to age 60 or within ten years of the onset of menopause symptoms. Health Secretary Robert F. Kennedy Jr. emphasized the shift towards empowering patients with evidence-based medicine, suggesting a need for a re-evaluation of how hormone therapies are perceived and prescribed.
The long-standing boxed warning, which has been in place for over two decades, cautioned against increased risks of clots and heart issues, referencing past data that has since been re-evaluated. Both doctors and drug manufacturers have advocated for updating or removing the warning, arguing that it has created unnecessary barriers for women who could benefit from these therapies.
Nonetheless, there remains contention within the medical community regarding the changes. Some experts are urging the FDA to implement a thorough and transparent review process before proceeding with label modifications. Many recommend that hormone therapies be used for limited periods in younger women experiencing early-stage menopause, particularly for those without complicating health risks.
The possibility of a broader benefit from hormone therapy, including reductions in heart disease and Alzheimer’s risk, was championed by Makary, who previously dedicated a chapter in his book to this subject. However, the certainty of these claims remains disputed. Controversially, the decision by the FDA to bypass its usual advisory committees and instead convene a select group of experts has sparked criticism. Detractors, including researchers from the National Center for Health Research, argue that robust scrutiny is essential to maintaining the FDA’s integrity and public trust.
As the FDA prepares for the implementation of new labeling guidelines, it aims to balance the therapeutic potential of hormone therapy against the existing risks, reflecting an evolving understanding of women’s health needs.