UPDATED: 12.4.09 @ 1:24 PM EST -- While the newly-proposed Vytorin label copy (if any?) is still not available from the index of background materials at the FDA web-portal -- this NEWLY-RELEASED additional document is. And here is the salient exerpt:
. . . .Four of the six serious cases described unlabeled events: increased TSH level (this case also described increased CK level), hyponatremia and hypophosphatemia, and two cases associated with in utero exposure in the first trimester (hemangioma congenital, respiratory distress syndrome with suspected newborn sepsis and antithrombin III deficiency). However, there were too few cases in any one area for meaningful assessment of pediatric risk for these events. An additional serious case described increased CK levels, but muscle complaints (ranging from asymptomatic increased CK levels to rhabdomyolysis) are labeled and commonly reported to AERS for the adult population on ezetimibe and or statin therapy.
However, it is notable that the pediatric study found the proportion of subjects with elevated CK values was numerically higher in the ezetimibe/simvastatin group (4, 3%) as compared to the simvastatin group (2, 2%). In contrast, the adult clinical trials found the incidence of CK >10 X ULN was 0.1% for ezetimibe co-administered with a statin versus 0.4% for statins alone. . . .
Note that it mentions "unlabeled events" -- and that might suggest where the label copy is headed. I'll keep you posted.
Here is the FDA's huge Friday data-dump -- what do you see?
Interestingly -- are there FDA-mandated label changes in the works for Vytorin, as well? It seems the file has been pulled from FDA's website (for now) -- I'll keep checking:
. . . .Content Server Request Failed
Unable to download 'UCM192102'. Unable to find latest released revision of 'UCM192102'. . . .
I'll keep checking the link.