FDA removes 'black box' warning label on hormone replacement therapy for menopause
The Food and Drug Administration said Monday it will remove the "black box" warning from hormone replacement therapy (HRT) products for menopause.
The change comes after two studies in the early 2000s claimed that there were major risks associated with HRT, including breast cancer. This led to the FDA placing its highest warning label on the drugs, prompting a significant decline in usage.
The public health agency estimates millions of women have avoided HRT out of fear of cancer or heart risks, based on an outdated analysis of data.
"This is, in my opinion, one of the greatest mistakes in modern medicine -- the demonization of hormone replacement therapy," FDA Commissioner Dr. Marty Makary said Monday.
An expert panel formed at the FDA in recent months reviewed the latest scientific studies and recommended the removal of the warning, Makary explained.
"Hormone replacement therapy may improve the health outcomes of women at a population level more than any other intervention, arguably, with the exception of, say, antibiotics or vaccines," Makary said.
The timing of when women initiate HRT "is an important nuance that has been lost" and "one of the design flaws" of the early 2000s studies, Makary said.
Current understanding is that the benefits of HRT outweigh the potential risks when taken before age 60 or within 10 years of the onset of menopause.
"This is really the result of doctors waving a flag in the air for decades of women who have said, 'Hey, we didn't feel like we got the right information,'" Makary said.
Consumers will see a different label on the products in several months, he added.
There are still risks associated with HRT and women considering it should speak with their doctor as it requires a prescription.
During a press conference on Monday, federal health officials including Health and hUman Services Secretary (HHS) Robert F. Kennedy Jr. lauded the FDA's decision to remove the warning label.
"After a thorough, evidence-based review of decades of scientific data, an expert panel and public testimony, the FDA is announcing today that it will remove the misleading black box warnings from all HRT products," Kennedy said.
The American College of Obstetricians and Gynecologists (ACOG), the largest medical organization of OB-GYNs, reacted positively to the news.
In a statement, Dr. Steven Fleischman, president of the group, said the label change will "increase access to hormone therapy" and "allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms."
"Like all medications, systemic estrogen products are not without risk, and their use should be based on an individualized conversation between patients and their clinicians," he added.
Dr. Rachel Rubin, one of the leading physicians behind the Monday announcement, praised the FDA's decision as truly historic.
"We have been begging for these changes for decades now, and to have it actually come to fruition is nothing short of revolutionary," Rubin told ABC News, after appearing alongside Kennedy, Makary and other physicians and administration officials.
Rubin, a urologist and sexual medicine specialist as well as an assistant clinical professor in urology at Georgetown University Hospital, described the rally to remove the black box warning labels as an "all hands on deck" grassroots effort of women and doctors. It included thousands of petitions for vaginal estrogen box labeling to be removed, according to Rubin.
"The labeling is just one huge hurdle that we had to cross," Rubin said. "Now the hard work begins of teaching clinicians how to do this, how to have nuanced discussions with their patients, how to write the prescriptions. Doctors don't know how to write the prescriptions, which is a disaster for women's health."
