Dr. David Borenstein on the FDA Erasing Hormone Therapy's Black Box Warning, and Why Men's Hormone Levels Are Getting More Attention Too
In February the FDA removed cardiovascular, breast cancer and probable dementia language from the boxed warning on six menopausal hormone therapy products. Testosterone prescribing in men has rebounded past its 2013 peak. Dr. David Borenstein says both point to the same shift.
In February 2026, the FDA approved labeling changes that remove language about cardiovascular disease, breast cancer, and probable dementia risk from the boxed warning, the agency's most prominent safety warning, on six menopausal hormone therapy products, spanning combination estrogen-progestogen therapy, estrogen-alone therapy, progestogen-alone therapy, and topical vaginal estrogen. The agency began removing the warnings in November 2025, following a review of the scientific literature, and 29 drug companies have since submitted proposed label revisions at the FDA's request.
"This decision reflects our commitment to follow the science wherever it leads," HHS Secretary Robert F. Kennedy Jr. said of the change in the FDA's announcement. FDA Commissioner Marty Makary added that the update was about "delivering on our promise to make sure women have accurate, scientifically grounded information."
The boxed warning had its roots in the Women's Health Initiative study decades ago, after which hormone therapy use collapsed and never fully recovered. The FDA's newer review found that randomized studies show women who start hormone therapy within ten years of menopause onset, generally before age 60, have reduced all-cause mortality and fewer fractures. Despite that, usage has remained strikingly low. In 2020, roughly 41 million American women were aged 45 to 64, yet only about 2 million women aged 46 to 65 actually received a menopausal hormone therapy prescription.
Dr. David Borenstein, owner of Manhattan Integrative Medicine and a physician who has served as chief investigator on a Pfizer-sponsored trial of sildenafil for sexual function in patients with spinal cord injury, says the label change validates an argument integrative and functional medicine physicians have been making for years. "Blanket, fear-based warnings kept appropriate candidates away from a therapy that, for the right patient at the right time, is protective rather than dangerous," Borenstein said. "The nuance was always in the timing and the individual risk profile, not in avoiding hormone therapy altogether."
His practice's approach to hormone therapy, he said, has never been a one-size-fits-all prescription. "Shared decision-making only works if the physician is actually assessing the individual patient, her age relative to menopause onset, her cardiovascular and cancer history, and her goals, rather than defaulting to blanket avoidance because of a decades-old warning label," he said.
The attention isn't limited to women's hormone therapy. Testosterone prescribing in men followed a similar arc. After peaking at 0.83% of male patients in 2013, the share with an active testosterone prescription fell to a low of 0.64% in 2021, before reversing sharply, climbing to 0.93% in 2025 and 0.95% in the first half of 2026. Every age group 30 and older has now surpassed its early-2010s peak, led by patients aged 50 to 64, who reached 1.57% in 2025, up from 1.30% in 2013.
Borenstein has been talking publicly about declining male hormone levels for over a decade. He was featured in The Huffington Post in 2015 discussing the hormonal changes men experience with age, sometimes informally called "male menopause," at a time when the topic drew far less mainstream medical attention than it does now. "Low testosterone symptoms get written off as normal aging more often than they should," he said. "Fatigue, mood changes, loss of muscle mass, low libido, and patients and even some physicians default to 'that's just getting older' instead of actually testing hormone levels and looking at the full picture."
His approach to men's hormone health mirrors his approach to menopause care. It means individualized testing before treatment, attention to lifestyle factors that influence hormone production, and treatment plans built around the specific patient rather than a standard protocol. "The common thread in both trends is the same," Borenstein said. "More willingness to actually measure what's happening hormonally, and less reflexive fear driving the decision either way. That's a good direction for medicine to move in, for men and women both."
As both the labeling change and the testosterone prescribing data suggest, Borenstein said the bigger shift underway isn't about any single hormone or demographic. "It's a move away from blanket rules in either direction, away from blanket fear, but also away from blanket prescribing," he said. "Good hormone care was always supposed to be personalized. It's taken the broader medical system a long time to catch up to that."
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
