FDA Orders Softening of Boxed Warnings on Menopausal Hormone Therapy Products
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The FDA has asked manufacturers of all menopausal hormone therapy products containing estrogen or progestogen to remove cardiovascular disease, breast cancer, and probable dementia risks from their boxed warnings, while keeping those risks in the precautions section of the labels. Several companies have already completed label changes approved by the FDA. The endometrial cancer risk for systemic estrogen-alone products was not part of the requested removal and remains in place. The move reflects the position that hormone replacement therapies can help women with bothersome menopausal symptoms. What remains open is whether all manufacturers will implement the changes and how clinicians will adjust prescribing practice in response to the revised labels.
Written by a model from the reports · updated 3 hours ago
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- U.S. FDAPickHormone Replacement Therapies Can Help Women with Bothersome Menopausal Symptoms
The FDA has asked makers of all menopausal hormone therapy (MHT/HRT) products containing estrogen or progestogen to remove cardiovascular disease, breast cancer, and probable dementia risks from the boxed warning and to update safety information in the labels; these risks remain in the precautions section. Several companies have completed label changes approved by the FDA. The endometrial cancer risk for systemic estrogen-alone products was not required to be removed.
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