12/20/2025
This is one of those moments that deserves a pause…
A black box warning is not a minor tweak. It’s the FDA’s strongest signal, and it forces a conversation that probably should have happened much earlier. Not about fear, not about sides, but about honesty, nuance, and individual risk.
Medicine has never been one size fits all, even when messaging tried to make it sound that way. Age matters. Biology matters. History matters. And pretending otherwise didn’t protect trust, it delayed accountability.
Changing guidance isn’t the problem. Denying uncertainty was.
The real question now is not “how did we get here,” but “how do we do better going forward,” especially when it comes to informed consent, individualized decisions, and asking questions without being dismissed.
Curious to hear your thoughts.
Does this restore trust, or expose how fragile it became?
What questions still feel unanswered?
Let’s talk in the comments.