FDA to remove “black box” warnings on hormone therapies for menopause

[FDA Headquarters - White Oak Campus]
hapabapa

Marking a pivotal moment in women’s health, the U.S. Food and Drug Administration (FDA) on Monday initiated actions to remove “black box” warnings, the agency’s strongest safety alert, from hormone replacement therapy products used for menopause.

HRTs were prescribed to treat menopausal symptoms for decades. But the early 2000s saw a significant decline in HRT prescriptions after the FDA added boxed warnings in reaction to a large government-funded study, which found that postmenopausal women using a type of HRT had higher health risks compared to those on placebo.

In a statement, the Department of Health and Human Services noted that the study was based on women with an average age of 63, more than a decade older than the onset of menopause in a typical female, and the hormone formulation they received is no longer commonly used.

“For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear,” FDA Commissioner Marty Makary said. The regulator said its decision is based on published scientific data, a public comment period, and a July meeting of an expert panel, which [https://www.hhs.gov/press-room/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy.html]called for the removal.

The FDA added that it is working with HRT makers to revise product labeling to remove warnings related to cardiovascular disease, breast cancer, and probable dementia. Concurrently, the agency announced the approval of a generic for Pfizer’s (PFE [https://seekingalpha.com/symbol/PFE]) hot flashes therapy, Premarin, and a non-hormonal treatment for hot flashes and other vasomotor symptoms linked to menopause.

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