In November 2025, the FDA removed the “black box warning” from medications used for menopausal hormone therapy, a decision that was immediately described as historic. A black box warning indicates serious health risks and strict prescribing limitations. Risk information has now been moved to the prescribing information rather than appearing on the frontal packaging.
The decision followed a re-evaluation of the 2002 studies that largely shaped previous restrictions. The average age of participants in those studies was around 63, significantly older than the age at which menopausal hormone therapy is typically initiated.
It is also important to recognize how different modern MHT is from earlier formulations. Today, these therapies are predominantly transdermal or vaginal rather than oral. This results in less hepatic load, reduced impact on coagulation, and a more physiological hormonal profile. In addition, current products increasingly use bioidentical hormones instead of synthetic estrogens and progestins.
This leads to an uncomfortable question.
Why are menopausal hormone therapy medications still treated with such caution, while combined oral contraceptives are not?
Modern menopausal hormone therapy uses hormone doses that are 10–50 times lower than those found in combined oral contraceptives. Yet contraceptives are often prescribed starting in adolescence and taken for decades. Even accounting for age-related risks in peri- and menopausal women, the long-term use of significantly higher doses of synthetic hormones in younger women also carries potential risks.
So why do low-dose therapies aimed at improving quality of life during menopause remain more tightly controlled and more feared than long-term contraceptive use with a far greater hormonal burden?
Perhaps in another 20 years, perspectives will change again.
I’d be interested to hear your thoughts.
