Safety Alerts & Recalls

What does this mean?

Invirase and Norvir are used to treat HIV infection and 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 first talk to their doctor or other healthcare professional before making any changes to their medications.

If you take Invirase and Norvir, please review your heart related medical history and current medications, non-prescription medicines, vitamins and herbal supplements with your healthcare professional at your next regular visit. Your doctor may want to perform tests to monitor the electrical activity of your heart. While taking Invirase and Norvir, 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.

If you have any additional questions or think you are experiencing side effects from your medications, please follow up with your doctor or other healthcare professional. You can report medication side effects 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 www.fda.gov/medwatch.

Warnings of Risk of Abnormal Heart Rhythm Added to Prescribing Information for Invirase

The U.S. Food and Drug Administration (FDA) has announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir). The new warnings alert patients and their healthcare professionals to the potential risk of changes in the electrical activity of the heart when Invirase (saquinavir) is used with Norvir (ritonavir), another HIV antiviral medication. Changes in the electrical activity of the heart may lead to abnormal heart rhythms. Patients at particular risk of heart problems with Invirase and Norvir are those with underlying heart conditions or those who have existing heart rate or rhythm problems. The FDA will also require that a Medication Guide be given to patients when picking up a prescription for Invirase. The Medication Guide will include information on the risk of abnormal heart rhythms.

This FDA action is in follow-up to the FDA's ongoing safety review of Invirase described in a February 2010 iGuard Safety Alert.

For more information, please visit: more information here

To view the February 2010 iGuard Safety Alert, please visit: more information here

Source: FDA
Publication Date: 2010-10-21
Last Updated: 2010-10-23

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