The U.S. Food and Drug Administration said Monday it would remove its sweeping warnings against hormone replacement therapy for menopausal women given its potential benefits to women’s health and the “statistically insignificant” risks of taking the drugs.
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” Health and Human Services Secretary Robert F. Kennedy Jr. said at a press conference announcing the end of labels that had been prominent on packaging for more than 20 years.
The hope is that more of the approximately 6,000 women who begin menopause daily in the U.S. will overcome hesitancy sparked by a now-outdated 2002 study of 26,000 women by the Women’s Health Initiative. When preliminary findings indicated that the pills boosted one’s risk of stroke, blood clots, breast cancer and other ailments, the study was halted, women and doctors were spooked, and prescriptions plummeted.
More nuanced results have come to light in the years since, and newer hormone formulations have been made available. Subsequent studies have pointed to a sweet spot for initiating hormone therapy, which poses almost no risks if begun before age 60 or within 10 years of the start of menopause. The risk of heart problems did not increase with estrogen use among women in their 50s, according to a September study, but did for women in their 70s.
In the 2002 study, participants included women well past menopause and asymptomatic. Their average age was 63, which meant that women in their 70s skewed the risk assessment higher, as The New York Times Magazine reported.
“That study was misrepresented and created a fear machine that lingers to this day,” Makary told The Associated Press.
The body stops producing estrogen during menopause, often leading to hot flashes, night sweats, brain fog and other symptoms. The loss of estrogen has implications for later life, since estrogen receptors reside not just in reproductive organs but also in the bones, brain and liver. New indications are that HRT at the right moment could reduce the risk of cardiovascular disease, Alzheimer’s disease, and bone fractures, the FDA said.
With News Wire Services
