Agency Concerns for Discussion by PADAC: SAFETY

• Fluticasone is systemically available (by PK) and impact on HPA axis can be measured after single dose in normals, 4 wks in COPD

  • Other systemic CS effects should be assumed
    

• Are data sufficient for labeling with regard to impact on:

  • Bone (BMD or fractures)?
  • Ocular structures (PSC/cataracts, IOP)?
  • HPA-axis?
  • Connective tissue, metabolic, or other systemic events?

Previous slide

Next slide

Back to first slide

View graphic version