Synagis (palivizumab) For Intramuscular Administration August 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 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
  • Blood and Lymphatic System Disorders
    • Severe Thrombocytopenia (platelet count <50,000/microliter)
  • General Disorders and Administration Site Conditions
    • Injection Site Reactions
  • Immune System Disorders
    • Severe acute hypersensitivity reactions and anaphylaxis...