Federal regulators at the Food and Drug Administration, through the Department of Health and Human Services, approved updated labels for three additional menopausal hormone therapy products from two applicants. [E1] HHS said the action removes boxed-warning statements concerning cardiovascular disease, breast cancer and probable dementia. [E3] The three products are estradiol transdermal patches. [E4]
In February, the FDA approved a labeling action covering six menopausal hormone therapy products. [E2] MarketScreener described the newly affected estradiol patches as therapies used to treat menopause symptoms. [E7] The Office on Women’s Health says hormone therapy treats symptoms and helps prevent osteoporosis. [E13]
The action leaves heart-disease and breast-cancer risks described elsewhere in the labeling. [E11] A boxed warning on whole-body estrogen-only products concerning endometrial cancer remains. [E12] The Office on Women’s Health says hormone therapy should not be taken solely to prevent heart disease. [E14] It also says experts do not yet know whether hormone therapy prevents dementia. [E15]
HHS said it is in close contact with manufacturers of FDA-approved menopausal hormone therapy formulations and is not aware, on current information, of an imminent nationwide shortage. [E5] The department said efforts to expand supply have doubled overall market output over the past 12 months. [E6] Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said manufacturers continue to expand capacity. [E10]
MarketScreener reported that women have struggled to find hormone-replacement treatments, including estrogen patches, amid rising demand. [E8] HHS did not immediately respond to Reuters’ request for the brands of the affected patches. [E9]