Invirase FDA Alerts
The FDA Alert(s) below may be specifically about Invirase or relate to a group or class of drugs which include Invirase (saquinavir).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for saquinavir
Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm
Oct 21, 2010
Audience: Cardiology, Infectious Disease
ISSUE: FDA notified healthcare professionals of new risk information added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections 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). Changes in the electrical activity of the heart may lead to abnormal heart rhythms, known as prolonged QT or PR intervals. A prolonged QT interval can lead to a serious abnormal rhythm called torsades de pointes, which can be fatal. A prolonged PR interval can lead to a serious abnormal rhythm called complete heart block. Torsades de pointes and complete heart block have been reported in patients taking Invirase with Norvir.
BACKGROUND: The medications Invirase and Norvir are given together to treat HIV infection. Norvir must be given at a low dose with Invirase in order to increase the level of Invirase in the body. 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 information was derived from a clinical study designed to study a drug’s impact on the electrical activity of the heart.
RECOMMENDATION: Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. An electrocardiogram should be performed prior to initiation of treatment. Physicians consider whether ongoing EKG monitoring is appropriate for patients and when it should be done. The Data Summary in the Drug Safety Communication provides more details.
FDA will 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.
[10/21/2010 - Drug Safety Communication - FDA]
Invirase (saquinavir): Ongoing safety review of clinical trial data
Feb 23, 2010
Audience: HIV/AIDS and cardiological healthcare professionals, patientsFDA notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir), antiviral medications given together to treat HIV infection.
The data suggest that together the two drugs may affect the electrical activity of the heart, known as prolonged QT or PR intervals. A prolonged QT interval can increase the risk for 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, known as heart block.
FDA's analysis of these data is ongoing. The agency will update the public as soon as this review is complete. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Invirase and Norvir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine,) or Class III (such as amiodarone) antiarrhythmic drugs, or in patients with a history of QT interval prolongation.
Patients should not stop taking their prescribed antiviral medications. Patients who are concerned about possible risks associated with using Invirase and Norvir should talk to their healthcare professional.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Phone: 1-800-332-1088
[02/23/2010 - Drug Safety Communication - FDA]
[02/23/2010 - News Release - FDA]
Invirase (saquinavir mesylate capsules and tablets)
Feb 9, 2005
Audience: Infectious disease and other healthcare professionalsRoche and FDA notified healthcare professionals about an Important drug interaction warning. Drug-induced hepatitis with marked transaminase elevations has been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir 100 mg/saquinavir 1000 mg twice daily (ritonavir boosted saquinavir). Roche now advises prescribers that Rifampin should not be administered to patients also receiving saquinavir/ritonavir (ritonavir boosted
saquinavir) as part of combination antiretroviral therapy (ART) for HIV infection.
[February 2005 - Letter - Roche]