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FDA MedWatch

MedWatch March 2009 Safety Labeling Changes - 38 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

04/07/2009 - The March 2009 posting includes 38 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/medwatch/safety/2009

The "Detailed View Page" 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: http://www.fda.gov/medwatch/safety/2009/mar09.htm

The following 19 drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Epzicom, OsmoPrep, Raptiva, Sporanox, Trizivir, Visicol, Diabeta, Macrobid, Macrodantin, Rocephin, Theophylline, Tracleer, Advair, Altace, Axert, Cymbalta, Frova, Lexiscan, and Spiriva

 

 

 

 

 

 

 

 

 

 

 

 

 
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