Label Changes for:

RotaTeq (rotavirus vaccine, live, pentavalent) oral solution

January 2010

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER)

 

July 2011

CONTRAINDICATIONS

  • ...history of intussusception, added

PATIENT PACKAGE INSERT

  • ..."Who should not receive RotaTeq", updated

 

January 2010

 

CONTRAINDICATIONS

  • Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

ADVERSE REACTIONS

Post-Marketing Experience 
  • Gastrointestinal disorders: Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)

PATIENT PACKAGE INSERT

Who should not receive RotaTeq?
  • Your child should not get RotaTeq if: He or she has Severe Combined Immunodeficiency Disease (SCID)

 

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