The Food and Drug Administration (FDA) announced Monday that it will remove black box warning labels from hormone replacement therapies (HRT) used to ease symptoms of menopause. Black box warning labels are the strongest safety warning the agency can give a medication and highlight serious health risks.
Warnings removed
Since 2003, the agency has required HRTs to carry black box labels warning users of an increased risk of heart attack, stroke, breast cancer and dementia.
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New labels, expected within six months, will recommend women start HRT within 10 years of menopause onset or before the age of 60 for general use.
FDA Commissioner Dr. Marty Makary said the policy reversal follows an extensive review of scientific evidence.
“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” Health and Human Services Secretary Robert F. Kennedy Jr. said on Monday. “We are returning to evidence-based medicine and giving women control over their health again.”
In July, the FDA hosted an expert panel to review the risks and benefits of HRTs and then invited the public to submit comments before it finalized its decision.
The American College of Obstetricians & Gynecologists (ACOG) commended the decision to remove black box labels.
“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,” ACOG president Dr. Steven J. Fleischman said in a statement.
“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,” the statement read. “ACOG also continues to recommend against the use of compounded estrogen products, which are not backed by the FDA for their safety or efficacy, and are not subject to the HHS announcement.”
The FDA also announced it approved two new HRT drugs with hopes to improve affordability and expand access.
Old and new evidence
In the mid- to late-90s, physicians routinely prescribed HRTs to relieve menopause symptoms. HRTs were also widely believed to prevent cardiovascular disease and osteoporosis. But then several studies debunked these touted health benefits.
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In 2002, researchers ended a large study after finding HRTs led to a higher risk of heart attack, coronary heart disease, stroke, breast cancer and blood clots.
In 2002, researchers prematurely ended a large, government-run study called the Women’s Health Initiative because they found that women taking HRTs had a higher risk of heart attack, coronary heart disease, stroke, breast cancer and blood clot. The study was robust; scientists followed more than 16,000 postmenopausal women for about five years, documenting health outcomes in one group of women who took HRTs and a second that did not.
“Overall health risks exceeded benefits,” the study’s authors concluded.
The FDA pointed out that the average age of women in this study was 63, more than a decade past the average age most start menopause. Study participants were also given a hormone formulation that is no longer used.
The FDA cited a slew of newer studies that have found that HRTs are not associated with increased cancer mortality, and that they might actually reduce the risk of heart attack, bone fractures, cognitive decline and Alzheimer’s disease.
