The Food and Drug Administration (FDA) has made a significant decision to reverse a 2003 ruling that placed strict black box warnings on hormone therapy products for menopausal women. This reversal comes after new research has shown that these treatments offer numerous health benefits for the heart, brain, and bones of menopausal women.
Commissioner Marty Makary announced this change in a Wall Street Journal op-ed, stating that the FDA is removing black box warning labels from various hormone therapy products used for menopausal women. These products include combined estrogen-progestogen, estrogen-only, other estrogen-containing, and progestogen-only treatments. The FDA is urging companies to update their product labels to remove specific mentions of cardiovascular, dementia, and breast cancer risks.
The initial black box warning was implemented based on a 2002 study called the Women’s Health Initiative, which suggested an increased risk of heart disease and breast cancer with hormone therapy. However, recent research has shown that hormone therapy can actually benefit menopausal women’s heart health by reducing insulin resistance and improving cardiovascular biomarkers. Additionally, these therapies can help alleviate common menopausal symptoms such as hot flashes, sleep disturbances, vaginal dryness, and painful intercourse.
Many clinicians have advocated for the removal of black box warnings, particularly for vaginal products where hormones are not fully absorbed into the bloodstream. A recent expert panel convened by the FDA discussed the risks and benefits of hormone therapies, with several physicians emphasizing the safety of local estrogen products.
While some clinicians agree with the decision to remove the black box warning, others have raised concerns about the lack of a formal advisory committee meeting to review the new data. The American College of Obstetricians and Gynecologists has supported reevaluating the label on local estrogen products, but recommended a separate process for systemic therapies.
Despite the removal of black box warnings, the FDA will continue to include adverse event information on hormone therapy products, tailored to each specific treatment. Updated labels will provide information on the best timing for initiating therapy, with experts recommending starting hormone therapy before the age of 60. Different therapy types will also have specific safety data reflecting their known risks.
Overall, the FDA’s decision to remove black box warnings from hormone therapy products is seen as a positive step towards providing more nuanced and evidence-based information to menopausal women. This change aims to better inform women about the risks and benefits of hormone therapy, allowing them to make more informed decisions about their health.
