Norvir (ritonavir oral solution) August 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View

Sections Modified

PRECAUTIONS

• PR Interval Prolongation
• Information for Patients
  • Patients should be informed that Norvir may produce changes in the electrocardiogram (eg, PR prolongation)...

ADVERSE REACTIONS

• Postmarketing Experience
  • Cardiovascular System
    • First–degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported (See PRECAUTIONS – PR Interval Prolongation).

PATIENT PACKAGE INSERT

• What Are the Possible Side Effects of Norvir?
  • Changes in the electrocardiogram (EKG)...