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U.S. Department of Health and Human Services

Safety

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Altabax (retapamulin) ointment

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

 

December 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Not for Systemic or Mucosal Use
  • The efficacy and safety of ALTABAX on mucosal surfaces have not been established.
 

ADVERSE REACTIONS

Clinical Studies Experience
  • Because clinical studies are conducted under varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice…
 

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • The magnitude of efficacy and the safety profile of ALTABAX in pediatric patients 9 months and older were similar to those in adults….
  

September 2010

Summary View

 

WARNINGS AND PRECAUTIONS

Not for Systemic or Mucosal Use subsection
  • Epistaxis has been reported with the use of Altabax on nasal mucosa