FDA removes warnings from hormone replacement therapy products
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced Monday that the black box warning on women’s estrogen-based products for hormone replacement therapy (HRT) will be removed.
“For more than two decades, the American medical establishment has had its turn[ed] It’s back on the women. “Millions of women were told to fear the therapy that could give them strength, peace and dignity through one of life’s most difficult transitions, menopause,” Kennedy said at a press briefing held at HHS headquarters.
“It ends today,” he added. “The FDA is beginning to remove a broad black box warning [on] Hormone Replacement Therapy Products for Menopause.”
The announcement was attended by his wife, actress Cheryl Hines, Kennedy’s daughter, and second wife Usha Vance.
Both Kennedy and Food and Drug Administration (FDA) Commissioner Marty Macari pointed to a study from more than 20 years ago, supported by the National Institutes of Health’s Women’s Health Initiative, that suggested hormone replacement therapy could potentially accelerate existing breast cancer in a woman’s body.
“The Women’s Health Initiative study was the largest study ever done in US history, a $1 billion study at the time, and you hear how that study was misrepresented and created a fear machine that remains to this day,” McCurry said. “The increase in breast cancer has no statistical significance. If we don’t have statistics, we don’t have science.”
“HRT has saved marriages, rescued women from depression, prevented children from going motherless,” he added.
Macari indicated Monday’s move would apply to both bioidentical hormones and synthetic hormones, saying the decision would be left up to individuals and their doctors.
Urologist Kelly Casperson spoke at the event and noted that 30 percent of women don’t take HRT because of black box labels.
Monday’s announcement was welcomed by some women’s health groups.
“Changes to some of the warning labels for estrogen products have been developed over several years, reflecting the dedicated support of physicians and patients across the country,” American College of Obstetricians and Gynecologists President Steven J. Fleischman said in a statement.
As Fleishman points out, her organization has advocated removing the black box label on low-dose vaginal estrogen because it limits its use to people dealing with vaginal and urinary symptoms of menopause.
“Today’s decision restores balance to women’s health policy. For years, the risks have been exaggerated and the benefits downplayed,” said Monique Yohanan, senior fellow at the conservative nonprofit Independent Women’s Health Policy. “Today, less than 5 percent of postmenopausal US women use menopausal hormone therapy, down from 25-30 percent two decades ago.”
“By aligning labels with current evidence, the FDA is giving physicians and women the clarity they deserve to make their informed choices,” added Yohanan.
Catherine Schubert, president and CEO of the Society for Women’s Health Research, said her group “deeply appreciates that the administration is aligning policy with current science, which shows that topical vaginal estrogen is safe and effective under appropriate clinical guidance for women with a history of breast cancer when non-hormone options are insufficient.”
The Menopause Society said it agrees with the FDA’s decision.
“However, systemic estrogen still carries potential risks that should be reviewed in detail as women begin therapy. According to the Menopause Society’s position statement on hormone therapy, the risk is lower for younger, healthy women who start hormone therapy near the menopause transition. The risk is higher for older women and those who start at an older age.”
This story was updated at 3:46 p.m
