F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments​

F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments​

F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments​

 

Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated.

A dozen physicians and researchers participating in a Food and Drug Administration panel on Thursday pleaded with the agency to “stop harming women” and remove the so-called black box warning from packages containing hormone treatments for menopause.

One after another, the panelists described patients who suffered from severe menopause symptoms — from hot flashes and painful sex to severe mood swings, forgetting names and even suicidal ideation — yet were scared away from estrogen-containing products by the labels.

The panelists were selected by Dr. Marty Makary, the F.D.A. commissioner, who has been an outspoken supporter of hormone therapy, and echoed his belief that the benefits of hormone therapy outweigh any risks.

“I am begging, we are all begging the F.D.A., please remove the black box warning,” said Dr. JoAnn V. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System and past president of the Menopause Society.

“History got it wrong,” said Dr. Heather Hirsch, who runs a telemedicine practice specializing in menopause care, adding, “We are doing harm in the name of ‘do no harm.’”

All menopause treatments containing the hormone estrogen carry a black box warning that the medication should not be used to prevent cardiovascular disease or dementia, and that it increases the risk of strokes, blood clots and probable dementia.

  

Creator: The New York Times (NYTHealth)

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