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The Food and Drug Administration on Thursday announced that Invirase (saquinavir) labeling has been changed to warn of potentially life-threatening heart rhythm abnormalities when the HIV drug is used in combination with Norvir (ritonavir). In February, FDA warned patients and health care providers about this possibility.When taken together, the two drugs can cause prolongation of the QT and PR intervals - indicators of heart rhythm activity seen on an electrocardiogram. "Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems," FDA said.
"Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm," the FDA notice said. "With torsades de pointes, patients may experience lightheadedness, fainting or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation."
"Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block," the advisory said. "With heart block, patients may experience lightheadedness, fainting or abnormal heart beats."
FDA also is requiring a medication guide for patients using Invirase that will describe these risks. The agency advises patients not to discontinue Invirase without talking to their health care professional.
"Patients should talk to their doctor if they have any concerns about their treatment," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "Certain drugs may interact with Invirase and increase the risk of developing these side effects, so patients should be sure to tell their doctor about other medicines they may be taking, including non-prescription medicines, vitamins, and herbal supplements."
For more information, visit: http://www.fda.gov/Drugs/DrugSafety/ucm230096.htm.
The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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