The FDA has removed the prominent "black box" warning about stroke, heart attack, and dementia risks from over 20 hormone-based drugs for menopause, citing updated evidence and a belief that the previous warning was outdated and created undue fear.
The U.S. Food and Drug Administration announced Monday it is removing the bold "black box" warning, the most serious type, from over 20 hormone-based drugs (like estrogen and progestin) used to treat menopause symptoms such as hot flashes and night sweats. This significant change, supported by FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr., comes as officials point to newer studies suggesting hormone therapy carries fewer risks when started before age 60 and within 10 years of menopause. The original 22-year-old warning, based on a landmark 2002 study, advised of increased risks of blood clots, heart problems, and other health issues, leading to a sharp decline in prescriptions. Many doctors and pharmaceutical companies had advocated for its removal, arguing it deterred women who could benefit. However, the decision process faced criticism for sidestepping the FDA's usual public advisory committee, instead convening a panel largely supportive of hormone therapy. While some, like Makary, suggest hormone therapy offers broader benefits beyond symptom relief, including reducing risks for heart disease and Alzheimer's, other experts, such as Dr. JoAnn Manson, caution that evidence for these wider benefits is not yet conclusive. The original risk information will still be available lower on the label, and a boxed warning will remain for women who haven't had a hysterectomy, recommending combined estrogen-progestin due to uterine cancer risks.
