FDA Commissioner on lifting warnings on hormone therapy for menopause
The Food and Drug Administration says it is removing the black box safety warnings from all hormone therapy creams, pills and other treatments prescribed to ease the symptoms of menopause and perimenopause.
The prominent warnings said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes.
"The FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even lifesaving treatment," FDA Commissioner Marty Makary said during a press conference Monday. "The FDA is taking action to remove the black box warnings from estrogen related products. This is based on a robust review of the latest scientific evidence."
It was time for a change, Makary told NPR's All Things Considered, because women have "been denied or never offered hormone replacement therapy despite the profound short term and long term benefits."
Instead of black box warnings on labels, he said, the agency wants to see a nuanced explanation of potential risks appear in a packaging insert: "The idea is to get better information in front of women."
The label change will make estrogen products more accessible to perimenopausal women and improve their lives, said Dr. Steven Fleischman, president of the American College of Obstetrics and Gynecology, or ACOG, in a statement.
"The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms."
Though he added that the medical organization's official guidance on estrogen therapy hasn't changed because it has "long advised" its members to talk to patients about their unique risks.
The FDA convened an expert panel in July to discuss removing them from at least low-dose vaginal estrogen. The agency then opened a docket to solicit comments from the public and received nearly 3,000 by the Sept. 24 deadline.
In its formal comment, ACOG wrote that it has "long encouraged" the agency to reevaluate warning labels on low-dose estrogen products administered vaginally, but it considers those separate from systemic estrogen products that deliver the hormone throughout the body, such as pills and patches.
ACOG's Fleischman said in Monday's statement that, "like all medications, systemic estrogen products are not without risk, and their use should be based on an individualized conversation between patients and their clinicians."
