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On October 21, 2010, the FDA announced that the label for saquinavir will now carry a warning of an increased risk for cardiac problems when the drug is used in combination with ritonavir. Taken together, these drugs can cause prolongation of the QT and PR intervals, potentially leading to serious arrhythmias, such as torsades de pointes and complete heart block. Patients with underlying heart conditions or problems with their heart rate or rhythm are at particularly elevated risk.
An electrocardiogram (ECG) should be performed before ritonavir-boosted saquinavir is initiated. Ongoing ECG monitoring may be appropriate in some patients.
A similar warning was added to the label of lopinavir/ritonavir in 2009 (JW AIDS Clin Care Apr 17 2009).