Label Changes for:
Veramyst (fluticasone furoate) nasal spray
July 2009
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009
CONTRAINDICATIONS
- Veramyst nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis
- Hypersensitivity reactions including anaphylaxis angioedema, rash, and urticaria, may occur after administration of Veramyst Nasal Spray. Discontinue Veramyst nasal spray if such reactions occur
ADVERSE REACTIONS
Postmarketing Experience/Immune System Disorders
- hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria
