Preliminary Data Suggest Heart Risk in Patients Taking Invirase/Norvir Combination Therapy

2/25/2010
The FDA has announced preliminary data suggesting that Genentech’s Invirase (saquinavir) taken in combination with Abbott Laboratories’ Norvir (ritonavir) may have potentially important adverse coronary effects, such as prolonged QT and PR intervals on an electrocardiogram. These effects may lead to abnormal heart rhythms, including torsades de pointes or heart block. Torsades de pointes may progress to ventricular fibrillation in some cases, with potentially increased risk in patients who have a history of QT interval prolongation. Although the FDA is currently analyzing data on these 2 medications, health care providers should be aware that Invirase and Norvir should not be used in those already taking medications known to cause QT interval prolongation, such as class IA (eg, quinidine) or class III (eg, amiodarone) antiarrhythmic drugs, or those with a history of QT interval prolongation. Patients should not stop taking their prescribed antiviral medications without first talking with their health care provider. They should also discuss any questions or concerns about Invirase with their health care provider and report any adverse effects to the FDA’s MedWatch program.
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