Secretary of Health and Human Services Robert F. Kennedy Jr. and Commissioner of the Food and Drug Administration Martin Makary announced Monday that the FDA will remove black box warnings from hormone replacement therapies. Photo by Aaron Schwartz/UPI | License Photo
The Food and Drug Administration announced Monday it would remove the black box warning on hormone replacement therapy for women.
Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary made the announcement at a press conference.
“We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,” Makary said at the press conference. “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.”
Makary and other agency officials said the warnings are based on outdated science and have discouraged women from taking hormone therapy.
The medications are commonly prescribed to treat menopause symptoms including, hot flashes, mood swings, difficulty sleeping and more. They replace estrogen and progesterone, which decline during menopause.
“Our big concern about the black box warning is that a lot of women are excited about walking out the office and then go home and read the black box and then never start it, because they get scared,” Dr. MargEva Cole, an obstetrician-gynecologist at Duke University School of Medicine, told NBC News.
The warnings were implemented after a 2002 clinical trial that said HRT increased the risk of breast cancer, heart attack and stroke in women. But the trial focused on a formulation of progesterone that isn’t often used today. It also focused on women in their 60s and 70s, while most women start HRT in their 40s or 50s.
The FDA said it will keep the warning of endometrial cancer risk on the packaging of systemic estrogen, which is delivered through patches, gels or pills.
“We now know, after having re-evaluated that data and doing additional research, that menopause hormone therapy is safe for a much broader range of people than we had previously understood,” Nora Lansen, chief medical officer at Elektra Health, a menopause care telehealth company, told Axios.
The FDA also said it has approved two new drugs for menopause. It approved a generic version of Premarin, and a non-hormonal treatment for vasomotor symptoms like hot flashes.
“Estrogen is a key hormone for women’s health. Every single part of a woman’s body depends on estrogen to operate at its best — including the brain, bones, heart, and muscles,” said Alicia Jackson, director of the Advanced Research Projects Agency for Health, in a statement.
“The removal of the black box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives.”
