Label Changes for:

Vfend (voriconazole) for Oral Suspension

March 2008

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

PRECAUTIONS

  • Drug Interactions
    • Table 11: Effect of Other Drugs on Voriconazole Pharmacokinetics
      • St. John's Wort
  • Monitoring of Pancreatic Function
  • Pediatric Use
    • There have been postmarketing reports of pancreatitis in pediatric patients

PATIENT PACKAGE INSERT

  • Who should not take Vfend?
    • St. John's Wort (herbal supplement)

CONTRAINDICATIONS

Coadministration of Vfend with St. John's Wort is contraindicated...

Hide
(web5)