Under the new Physicians Labeling Rule that is supposed to make labeling clearer, the warnings and precautions have been combined into a single section so it’s actually harder to see what is more significant. Even if it’s in the old labeling format it’s supposed to be switched over.

I also have to question why FDA would put hepatotoxicity and death in precautions in the first place. A precaution is something you should look for ahead of time (e.g. first dose hypotension) and is not so serious.

I believe this highlights some of the subtle ways in which FDA is helping Pharma hid safety info even when it is available.

Congress needs to specify clear criteria for various levels of safety information.