FDA Removes ‘Black Box’ Warning on Menopause Hormone Therapy/ Newslooks/ WASHINGTON/ J. Mansour/ Morning Edition/ The FDA will remove its boxed warning on hormone-based menopause drugs, citing updated research showing lower risks for women under 60. While some experts praise the move as science-based, others criticize the process as lacking transparency. The updated label reflects a shift toward individualized, age-sensitive risk assessment.
FDA Hormone Therapy Label Change: Quick Looks
- Boxed warning removed from over 20 menopause hormone treatments
- Estrogen and progestin products no longer flagged for broad stroke, heart, dementia risks
- New label reflects lower risks for women under 60 or <10 years post-menopause
- FDA Commissioner Marty Makary says current label was outdated
- Health Secretary Robert F. Kennedy Jr. says decision empowers women
- Critics say FDA bypassed independent advisory panel in decision process
- 2002 study once linked hormone therapy to serious health risks
- Newer data shows lower risks in younger, early-menopause users
- Vaginal creams and low-dose options to receive separate labels
- Experts remain divided over long-term benefits vs. risks
Deep Look
FDA Eases Warning on Hormone-Based Menopause Drugs, Citing New Research and Benefits
In a significant shift in women’s health policy, the U.S. Food and Drug Administration announced Monday that it will remove its strongest warning — the boxed warning — from a wide range of hormone-based menopause therapies. The decision reflects new evidence suggesting that the risks of these drugs are far lower when used by younger women or those closer to the onset of menopause.
The change affects more than 20 FDA-approved treatments containing estrogen or a combination of estrogen and progestin, commonly used to relieve menopausal symptoms like hot flashes and night sweats. These therapies have carried the boxed warning — the FDA’s most serious label — since 2002, cautioning about elevated risks of stroke, heart disease, dementia, and cancer.
Makary and Kennedy Defend Change as “Evidence-Based”
FDA Commissioner Dr. Marty Makary, a long-time critic of the warning label, has advocated for a more balanced view of hormone therapy. In a commentary published in The Journal of the American Medical Association (JAMA) on Monday, Makary and agency colleagues wrote that the label was “outdated” and that its removal “reflects a more nuanced, evidence-based communication of hormone therapy risks.”
Health Secretary Robert F. Kennedy Jr. echoed that sentiment, calling the move a necessary correction: “We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts.”
Makary emphasized that when started before age 60 or within a decade of menopause onset, hormone therapy poses minimal health risks for most women and may carry additional health benefits. These include potential reductions in the risks of heart disease, osteoporosis-related fractures, and even Alzheimer’s.
Not Everyone Agrees
However, not all experts are convinced. Some researchers — including those who helped generate the original safety data — have pushed back against the removal of the warning, questioning whether the benefits truly outweigh the risks.
Critics also slammed the FDA’s decision-making process, arguing it lacked transparency. Instead of convening a formal advisory committee, Makary hosted a private July meeting with handpicked researchers and clinicians, many of whom support hormone therapy and have ties to pharmaceutical companies or advocacy campaigns like “Unboxing Menopause.”
Diana Zuckerman, president of the National Center for Health Research, accused the FDA of circumventing scientific norms. “This undermines the agency’s credibility,” she said, calling for public review and scientific debate before making such a sweeping change.
Nearly 80 scientists signed a letter demanding a formal advisory panel review the proposed changes — a step the FDA skipped.
The Origins of the Warning
The now-removed warning label was originally based on a landmark 2002 study involving over 26,000 women, which linked long-term hormone therapy use to elevated risks of stroke, blood clots, breast cancer, and other conditions — particularly among older women. As a result of those findings, hormone therapy prescriptions dropped sharply across all age groups.
But in the decades since, newer studies have suggested that those earlier findings may not apply uniformly across age groups. A recent re-analysis of the original data, published in September, found that women in their 50s using estrogen did not show elevated heart risks, while those in their 70s did. For women in their 60s, the evidence remained unclear, prompting calls for caution.
A Shift Toward Personalized Risk Assessment
FDA officials say the updated labels reflect a more individualized, age-sensitive approach to prescribing hormone therapy. The revised information suggests the drugs should still be used with caution, but can be appropriate for younger women with no complicating risk factors, such as breast cancer or preexisting heart conditions.
Notably, the agency will retain a boxed warning for women who have not had a hysterectomy, since estrogen-only therapy increases the risk of endometrial cancer unless balanced with progestin.
Also, lower-dose and locally applied products — such as vaginal creams, tablets, and rings — will receive their own revised labeling, given their unique delivery methods and potentially reduced systemic risks.
Hormone Therapy: Underused or Overcautioned?
Dr. Makary has long argued that hormone therapy is underused due to fear generated by the 2002 study and subsequent warning label.
In his book, he wrote that “with the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women more than hormone therapy.”
That assertion remains deeply controversial. Some researchers maintain that large-scale benefits are overstated, while others fear that removing the warning could open the door to overprescribing — particularly among women outside the recommended age range.
Still, many doctors view the change as overdue. Dr. Lauren Streicher, a menopause specialist not involved in the FDA’s meeting, said, “This will allow doctors and patients to make informed decisions without unnecessary fear.”
What’s Next for Patients and Providers
Under the new guidelines, the original boxed warning language will still be accessible to physicians, but will appear lower in the prescribing information. The hope is that this shift will encourage more open conversations between patients and healthcare providers, focusing on individualized risk rather than blanket restrictions.
Whether this change results in greater use of hormone therapy remains to be seen, but it is clear that the FDA is moving toward a more flexible regulatory framework — one that accounts for newer science and the realities of patient-centered care.
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