Shots – Health News
Watch: FDA Commissioner on lifting warnings on hormone therapy for menopause
The Food and Drug Administration says it is removing the black box safety warnings from all hormone therapy creams, pills and other treatments prescribed to ease the symptoms of menopause and perimenopause
The prominent warnings said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes
Shots – Health News
Doctors urge FDA to remove black box warning on hormone therapy for menopause
“The FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even lifesaving treatment,” FDA Commissioner Marty Makary said during a press conference Monday. “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.”
It was time for a change, Makary told NPR’s All Things Considered, because women have “been denied or never offered hormone replacement therapy despite the profound short term and long term benefits.” (Watch the interview above.)
Instead of black box warnings on labels, he said, the agency wants to see a nuanced explanation of potential risks appear in a packaging insert: “The idea is to get better information in front of women.”
The label change will make estrogen products more accessible to perimenopausal women and improve their lives, said Dr. Steven Fleischman,president of the American College of Obstetrics and Gynecology, or ACOG, in a statement
“The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms.”
Though he added that the medical organization’s official guidance on estrogen therapy hasn’t changed because it has “long advised” its members to talk to patients about their unique risks
The FDA convened an expert panel in July to discuss removing them from at least low-dose vaginal estrogen. The agency then opened a docketto solicit comments from the public and received nearly 3,000 by the Sept. 24 deadline
In its formal comment, ACOG wrote that it has “long encouraged” the agency to reevaluate warning labels on low-dose estrogen products administered vaginally, but it considers those separate from systemic estrogen products that deliver the hormone throughout the body, such as pills and patches
ACOG’s Fleischman said in Monday’s statement that, “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.”
Doctors had gone back and forth about the risks versus benefits of hormone therapy for years. In 2002, researchers rang the alarm about them because a long-term study called the Women’s Health Initiative found that hormone therapy was associated with increased risk of cancer and stroke. Since then, additional research has shown those risks were overstated, and the therapy can instead reduce heart disease when prescribed earlier.
“Fifty million women since that study 23 years ago have been denied or never offered or talked out of the life changing lifesaving benefits of hormone replacement therapy – including my mom,” Makary said during the press conference Monday about the label changes
Makary added doctors are often taught in medical school that menopause is mild and lasts a few years, but that’s wrong. “The symptoms occur in over 80% of women. They last, on average, eight years. And for many women, they are severe, even debilitating: mood swings, night sweats, weight gain, hot flashes, divorce.”
Although doctors have pushed to have the black box warnings removed, they say the special panel the FDA convened in July ded the rigor of the usual approach
“While we appreciate the FDA Expert Panel’s interest in reevaluating the label warnings on hormone therapy, a brief panel such as the two-hour July 17th Expert Panel should not be considered an adequate substitute for an advisory committee meeting,” ACOG wrote in its formal comment to the agency
FDA advisory committees are made up of independent experts who evaluate scientific presentations, discuss and debate the evidence on a given topic and then vote on recommendations for the FDA. The agency doesn’t always follow its committees’ recommendations, but it usually does
“Forgoing the advisory committee process runs counter to the Agency’s stated goal to increase transparency.” ACOG writes. “Therefore, ACOG urges the FDA to delve deeper into the benefits of low-dose vaginal estrogen for [genitourinary syndrome of menopause] and systemic estrogen therapy for vasomotor symptoms by convening separate advisory committee meetings, including opportunities for public engagement, before making decisions on possible labeling changes for these distinct menopausal hormone therapy options.”
Makary said during the press conference that the agency chose not to have an advisory committee meeting, “because [advisory committees] are bureaucratic, long, often conflicted and very expensive.” He said his FDA is doing more expert panels instead, which are less strict and can be more spontaneous but remain robust
In an email to NPR, the agency shared several studies in support of its decision. The studies showed that these hormone therapies reduced the risk of Alzheimer’s disease, heart attack and hip fracture. The findings aren’t new, however, and were published between 1980 and 1996. The agency also cited an analysis of 30 studies from 1966 through 2003 that showed starting hormone replacement therapy earlier could save lives. It was published in 2004.
During the press conference, Makary held up a study he said was published in the medical journal Cancerfrom three years ago that showed a decrease in coronary heart disease among women using hormone replacement therapy
