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 (Invirase, Genentech), describing potentially life-threatening side effects on heart function when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, FDA announced.

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 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 who have existing heart rate or rhythm problems are at greatest risk, the agency said.

FDA made the decision to ensure that providers and patients are adequately informed of the risks, an agency spokeswoman told Drug Topics.