HHS and the FDA are taking formal steps to remove boxed warnings from hormone replacement therapy products used to treat menopausal symptoms.
The FDA began the process after reviewing updated scientific literature, convening an expert panel in July and opening a public comment period, according to a Nov. 10 news release from the FDA. Officials said the existing boxed warnings are based on outdated research. The agency is now working with manufacturers to revise product labels and eliminate warnings about risks of cardiovascular disease, breast cancer and probable dementia. A warning for endometrial cancer will remain for estrogen-only therapies.
Boxed warnings were originally added in the early 2000s after a Women’s Health Initiative study found a statistically non-significant increase in breast cancer diagnoses. The study involved women with an average age of 63 and used a hormone formulation that is no longer commonly prescribed.
The FDA recommends initiating hormone therapy within 10 years of menopause onset or before age 60 for systemic HRT. Data suggests this timing may reduce cardiovascular disease risk by up to 50%, Alzheimer’s disease risk by 35% and bone fracture risk by 50% to 60%, the release said.
The agency also approved two new treatments: the first generic version of Premarin in more than 30 years and a nonhormonal drug for moderate to severe vasomotor symptoms, such as hot flashes.
