New push for FDA to remove ‘black box’ warnings from menopause products

The debate over whether to use hormone therapy to treat menopausal women continues, as a Food and Drug Administration (FDA) expert panel weighs in.

The panel, consisting of 12 people, is urging the use of such treatments and asking the FDA to remove “black box” warnings from the products. It has long been argued whether the listed side-effects of such hormone replacements are overblown, while some claim that long-term effects are worthy of some concern.

JoAnn Pinkerton is the professor of obstetrics and gynecology and division director of midlife health at the University of Virginia Health System. As a panelist, she encouraged the FDA to “stop harming women” by removing the warnings.

“I am begging the FDA, and all of us are begging: Please remove the black box label,” she said.

“Menopausal hormone therapy is effective for vasomotor symptoms and vaginal dryness, but those are the only proven symptomatic benefits,” argued professors Adriane Fugh-Berman and Barbara Mintzes in an editorial on the matter. “Serious harms, including stroke, pulmonary embolism, gallbladder disease, and increased breast cancer risk, are trivialized or ignored in current narratives.”

A long-term study on the effects of hormone therapy for menopausal women, dubbed the Women’s Health Initiative (WHI), resulted in a significant drop in physicians recommending and prescribing the treatment.

“The randomized controlled trial looked at the impacts of estrogen use to treat menopause symptoms on more than 10,000 women in the 1990s and the impacts of using both estrogen and a progestin hormone on more than 16,000 women,” The Hill reported. “Both arms of the study were stopped when researchers found the estrogen-progestin regimen increased the risk of invasive breast cancer, pulmonary embolism and stroke, while estrogen-only increased the risk of stroke.”

Following this, treatments for menopause that use estrogen have come with “black box” warning labels declaring that the medications come with “increased risk for stroke, deep vein thrombosis and dementia. Labels also state estrogen and estrogen plus progestin therapy should not be used to treat cardiovascular disease or dementia.”

Writer/Columnist

Sierra Marlee is a millennial whose hunger for the truth in a world of fake news has led her to BizPac Review.

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