The FDA is removing the black box safety warnings on hormone therapy products for menopause, citing a more nuanced understanding of their benefits and risks, and emphasizing the potential health benefits of these therapies when prescribed appropriately. The decision follows public comments and studies suggesting hormone therapy can reduce risks of Alzheimer's, heart attack, and fractures, despite past concerns about cancer and stroke risks.
The U.S. Department of Health and Human Services and the FDA are removing broad black box warnings from hormone replacement therapy (HRT) products for menopause, based on new scientific evidence showing benefits and reduced risks, aiming to empower women with better treatment options and improve access to affordable HRT medications.
The FDA is considering removing some black box warnings on menopause hormone therapy, which has been historically linked to risks like stroke and breast cancer. Recent research suggests that age, timing, and dosage significantly influence safety, prompting healthcare professionals to advocate for a nuanced approach. Women like Isabel Kallman are weighing the benefits of symptom relief against potential risks, emphasizing the need for personalized medical advice. Experts call for more scientific assessment and public input before any regulatory changes are made.