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Combination HIV drug regimen may cause arrhythmia, sudden death
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The FDA will review clinical trial data to determine whether combination antiviral therapy with saquinavir and ritonavir, two antiviral medications used to treat HIV, increase a patient’s risk for prolonged QT and PR intervals that can result in torsades de pointes and sudden death, the agency announced today in an early communication.
They encourage physicians to remain aware of the potential for cardiac risk among patients taking these medications, but emphasized that analyses are ongoing. In the meantime, patients should continue to take prescribed antiviral medications. However, neither saquinavir (Invirase, Genentech) nor ritonavir (Norvir, Abbott Laboratories) should be prescribed to patients already taking medications known to cause QT interval prolongation, including Class IA or Class III antiarrhythmic drugs, or patients with a history of QT interval prolongation.
The FDA encourages healthcare professionals and patients to report adverse events to the agency’s MedWatch Safety Information and Adverse Even Reporting Program.
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