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Invirase label to warn of abnormal heart rhythm

October 22, 2010 12:31 AM UTC

FDA approved an updated label for Invirase saquinavir from Roche (SIX:ROG; OTCQX:RHHBY) to warn of the risk of abnormal heart rhythms when the HIV drug is boosted with Norvir ritonavir from Abbott Laboratories (NYSE:ABT). In February, FDA said it was reviewing the safety of Invirase after data from a QT study of the combination in healthy volunteers showed a dose-dependent prolongation of the QT and PR intervals, which could lead to torsades de pointe -- a frequently fatal arrhythmia -- and heart block, respectively. ...