FDA Drug Safety Communication

FDA is notifying the public that new risk information has been added to the label of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used with another antiviral medication, Norvir (ritonavir). The medications Invirase and Norvir are given together to treat HIV infection.

In February 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase in combination with Norvir.

This new risk information has been added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections of the Invirase label. In addition, FDA will require that a Medication Guide be given to patients when picking up a prescription for Invirase.

Healthcare professionals should:

-Read the new changes in the Invirase label carefully if you are considering or currently prescribing this medication to your patients.

-Note that Invirase is contraindicated in certain patients.

-An electrocardiogram (EKG) should be performed prior to initiation of treatment. In addition, consider whether ongoing EKG monitoring is appropriate for your patient and when it should be done. A cardiology consult is recommended if drug discontinuation or interruption is being considered on the basis of EKG assessment to confirm EKG findings.

-Advise patients to contact a healthcare professional immediately if they experience symptoms of an abnormal heart rate or rhythm while taking Invirase/Norvir.

View the full FDA Drug Safety Communication on FDA.gov