Seroquel (quetiapine fumarate) Tablets

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

Summary View

Sections Modified

PRECAUTIONS

• Leukopenia, Neutropenia and Agranulocytosis
• Information for Patients
• Laboratory Tests

ADVERSE REACTIONS

• Vital Signs and Laboratory Studies
  • In postmarketing clinical trials, elevations in total cholesterol (predominantly LDL cholesterol) have been observed.
• Postmarketing Experience
  • Cardiomyopathy
  • Myocarditis

 

January 2008 Label not available at this site.