Removing Safety Warnings for Menopausal Hormone Therapy Undermines FDA’s Credibility, Encourages Inappropriate Off-Label Use
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is removing the boxed warning — the agency’s most prominent warning — from the prescribing information of all menopause hormone treatments containing estrogen. These treatments are approved for vasomotor symptoms due to menopause, vulvar, or vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis.
According to FDA Commissioner Martin Makary, the prescribing information for these drugs will be updated to remove boxed warnings about the increased risk of blood clots and stroke, probable dementia and breast cancer, as well as the recommendation that these treatments should be used at the lowest dose and for the shortest duration consistent with treatment goals and risks. Previously, Public Citizen urged the FDA to consider labeling changes for menopausal hormone treatments only after undertaking an impartial rigorous assessment of all available evidence, convening an advisory committee of independent experts, and addressing gaps in the understanding of the risks of these treatments with new research.
Nina Zeldes, PhD, a health researcher at Public Citizen’s Health Research Group, issued the following statement:
“HHS and the FDA have claimed that the removal of the boxed warning for hormone replacement therapy will ‘restore gold-standard science to women’s health.’ In fact, the opposite is true. These treatments have well documented cardiovascular, cognitive and cancer safety risks. Overblown press conference announcements and unsubstantiated labeling updates do not protect women’s health. The FDA should advance women’s health by making decisions based on high-quality data from long-term randomized controlled trials and the formal advisory committee process.
“In today’s announcement the FDA also seemed to blatantly promote the off-label use of hormone replacement therapy for some conditions for which it is not approved, such as preventing cardiovascular disease and cognitive decline. Unsubstantiated claims by senior FDA officials about the effectiveness of hormone replacement therapy for unapproved indications undermines public trust in the agency’s decision-making.
“The U.S. Preventive Services Task Force has consistently recommended against hormone replacement therapy for the prevention of chronic conditions in post-menopausal women. Instead of making unsubstantiated claims about improving women’s health, the FDA should encourage or fund research that establishes the benefits and risks of short-term and long-term use of hormone replacement therapy.”