FDA MedWatch - December 2009 Drug Safety Labeling Changes: 28 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

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Title: FDA MedWatch - December 2009 Drug Safety Labeling Changes: 28 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch December 2009 Drug Safety Labeling Changes posting includes 28 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194965.htm

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:


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