RotaTeq (rotavirus vaccine, live, oral, pentavalent) Oral Solution

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

ADVERSE REACTIONS

• Postmarketing Experience
  • Gastrointestinal Disorders
    • Intussusception (including death)

PATIENT COUNSELING INFORMATION

PATIENT PACKAGE INSERT

• What other important information should I know?
  • ...Death due to intussusception has also occurred...

 

The April 2008 Label not available at this site.