MedWatch - March 2009 Safety-Related Drug Labeling Changes - Summary

Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW =BOXED WARNING,
C =CONTRAINDICATIONS,
W =WARNINGS,
P =PRECAUTIONS
AR =ADVERSE REACTIONS,
PPI/MG =PATIENT PACKAGE INSERT/MEDICATION GUIDE

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MedWatch - March 2009 Safety-Related Drug Labeling Changes - Summary