Salmon never disappoints -- and always has additional (and generally deeper) observations, in the comments. This time, it was in respone to my partial listing of the labeling/warnings as part of the FDA approval, this morning. Do take a look:
. . . .Unforunately, the bold AEs that you put forward are class effects and include class effects known among the older classical antipsychtics. So:
Increased risk of death in elderly. They all have black box warnings now. But we knew this from Zyprexa just look at the summary basis of approval. It was only after Lilly pushed it off-label for years that FDA finally did something.
Asenapine. Avoided studying in the elderly but just place it on the tongue It's so easly) and voila "no more grandma." That of course can be explained away as a class effect or inapproriate administration (not for dementia or not sublingual).
CVAs - strokes, TIAs might be due to those pesky effects on serotonin or also possibly narrowing of arteries and veins -- now wasn't SP looking at intimal media thickness. Yes?
Probably won't be picked up up as anything unusual.
NMS - nasty. Your body cooks itself. Interesting how this appears related to effects on mitochondrial as is effects on diabietes, lipids, etc.. Hard to tease out and hard to tell which drug it's worse with. Oh Well just label it, and hope for the best: asenapine -- just like we do with the others.
TD - long term may be 25% with OD of older antipsychotics like haldol less with appropriate dosing. May be 10-15% with newere atypicals. This this due to better dosing or different receptor profiling. Doesn't matter -- may be better -- but this is largely not life-threatening.
Phen-Fen like cardiovascular toxicity. NOT MENTIONED.HEPATOTOXICITY -- Dose and time dependent -- NOT MENTIONED.
BIRTH DEFECTS - NOT MENTIONED.
Other lesser effects not mentioned.
It's the comparisons and risks in certain populations with the not mentioned I'm really interested in. If they mention a couple of nasty things you've got to wonder why they're so afraid to mention other nasty AEs.
-- Salmon
August 14, 2009 4:24 PM. . . .
I do wonder, though, whether it will matter at all, to prescribing physicians, that the FDA has (as of today) only approved Saphris in acute settings -- not longer term maintenence.
