HIV drug saquinavir to get new safety data on label

New safety information has been added to the label for the HIV antiviral drug saquinavir mesylate (Invirase, Genentech), describing potentially life-threatening side effects on the heart when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, according to FDA.

New safety information has been added to the label for the HIV antiviral drug saquinavir mesylate (Invirase, Genentech), describing potentially life-threatening side effects on the heart when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, according to FDA.

In February 2010, the agency warned patients and healthcare professionals that when used together, saquinavir and ritonavir could cause prolongation of the QT and PR intervals - indicators of abnormal heart rhythm activity seen on an electrocardiogram. FDA will also require a medication guide for patients who use saquinavir, describing potential risks.

Patients with underlying heart conditions or those that have existing heart rate or rhythm problems are at greatest risk, the agency said.

FDA made the decision to require additional safety information to assure that providers and patients are adequately informed of the risks, an agency spokeswoman told Formulary.