Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm
AUDIENCE: Cardiology, Infectious Disease
ISSUE: FDA notified healthcare professionals of new risk information
added to the Warnings and Precautions, Contraindications, and Clinical
Pharmacology sections of the antiviral drug Invirase (saquinavir),
describing a potential change in the electrical activity of the heart
when Invirase is used with another antiviral medication, Norvir
(ritonavir). Changes in the electrical activity of the heart may lead
to abnormal heart rhythms, known as prolonged QT or PR intervals. A
prolonged QT interval can lead to a serious abnormal rhythm called
torsades de pointes, which can be fatal. A prolonged PR interval can
lead to a serious abnormal rhythm called complete heart block.
Torsades de pointes and complete heart block have been reported in
patients taking Invirase with Norvir.
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