Safety Alerts & Recalls

What does this mean?

The review of the available safety information for the use of INVIRASE with NORVIR is ongoing and the FDA will update the public when the final review is complete. Since INVIRASE and NORVIR are used to treat a serious condition, you should continue to take your prescribed antiviral medications. Stopping your medications without the guidance of your doctor can lead to problems such as drug resistance. Patients who are concerned about possible risks associated with using INVIRASE and NORVIR should talk to their doctor or other healthcare professional.

If you are currently using INVIRASE, you should:

1) Continue taking INVIRASE, NORVIR, and your other medications.

2) Discuss any questions or concerns you have about INVIRASE with your doctor or other healthcare professional.

3) Review your heart related medical history and current medications with your doctor or other healthcare professional to determine if you should continue using INVIRASE.

4) Watch for signs of lightheadedness, fainting, or abnormal heart beats and contact your doctor or other healthcare professional right away if they occur - these may be signs of changes in the electrical activity of your heart.

5) Report any side effects with INVIRASE to FDA's MedWatch program by telephone at 1-800-332-1088 by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

If you have any additional questions or think you are experiencing side effects from INVIRASE, please follow up with your doctor or other healthcare professional.

The FDA Is Reviewing A Possible Safety Concern for HIV Drug Combination of INVIRASE with NORVIR

The U.S. Food and Drug Administration (FDA) is reviewing clinical trial data about a potentially serious effect on the heart from the use of INVIRASE (SAQUINAVIR) in combination with NORVIR (RITONAVIR). The data suggest that together the two drugs may affect the electrical activity of the heart. The changes to the electrical activity of the heart possibly associated with these drugs, known as prolonged QT or PR intervals, can increase the risk for abnormal heart rhythms, including a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop; this is known as heart block and can affect how fast the heart is able to beat.

INVIRASE and NORVIR are antiviral medications given together to treat HIV infection. Typically, NORVIR is given at a low dose with INVIRASE in order to increase the level of INVIRASE in the body. This is a process known as "boosting" and is described in the prescribing information for INVIRASE.

For more information: more information here

Source: FDA
Publication Date: 2010-02-23
Last Updated: 2010-02-28

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