All articles tagged with #black box warning
US health leaders are advocating for the removal of the black box warning on hormone therapy for menopause, citing new evidence of its benefits and calling for balanced, individualized treatment discussions, though some experts warn of potential risks and the need for nuanced understanding.
The FDA has decided to remove the black box warning on hormone replacement therapy for menopause, citing new evidence of its benefits and nuanced risks, which could lead to increased use among women experiencing menopause symptoms.
The FDA has removed the 'black box' warning on hormone replacement therapy for menopause, citing new research that shows the treatments are safer than previously thought, which may increase their use among women and doctors. The agency will still warn about endometrial cancer risk and has approved two new menopause-related drugs. This change follows a reevaluation of past studies linking hormone therapy to serious health risks, and reflects a broader shift in conversations about women's health during midlife.
The FDA plans to remove the black box warning from many hormone treatments for menopause, a move expected to increase access and prescriptions for hormone therapy, which has been underused due to fears of health risks. Experts argue that the warning has unnecessarily scared women away from beneficial treatments, and recent data suggest that hormone therapy is safer for women under 60 or within 10 years of menopause, potentially improving quality of life and health outcomes.
The FDA plans to remove the 'black box' warning labels from many menopause hormone therapy drugs, acknowledging that previous fears based on flawed research led to millions of women being denied beneficial treatment, which could improve heart health, cognitive function, and bone density. FDA Commissioner Dr. Marty Makary called the demonization of hormone therapy an 'American tragedy' and emphasized the importance of updated, nuanced understanding and patient-doctor discussions.
The FDA is considering removing or modifying the black box warning on hormone replacement therapies for menopause symptoms, citing evidence that the warning may be overly broad and harmful by discouraging beneficial treatments for women, especially when started early in menopause. Experts argue that certain forms of hormone therapy, like vaginal estrogen, may be safe and beneficial, and that the current warning has led to significant undertreatment of menopausal symptoms, impacting women's quality of life.
Doctors are urging the FDA to remove the black box warning on low-dose estrogen hormone therapy for menopause, arguing that the warning overstates risks and discourages women from using beneficial treatments. The panel discussion highlighted evolving scientific understanding and calls for regulatory change, though some experts remain cautious about broad removal of warnings for systemic estrogen. The debate underscores the need for balanced risk-benefit analysis in hormone therapy for menopausal women.
An FDA expert panel recommended removing the black box warning on menopausal hormone therapies, citing potential benefits and questioning the overemphasis on risks, which could lead to increased use of these treatments for menopausal women.
Despite the FDA issuing a black box warning for the asthma drug Singulair due to harmful neuropsychiatric side effects in pediatric patients, a recent study by OU-Tulsa shows that prescriptions for the drug have only slightly decreased, with 31 million Americans still being prescribed the high-risk medication in 2021. Concerns about mental health changes in children have prompted calls for stronger restrictions, as researchers question whether clinicians are well-informed about the drug's negative side effects and urge healthcare providers to proactively educate themselves and monitor patient symptoms.