FDA MedWatch Alert! PDF Print

 

 MedWatch The FDA Safety Information and Adverse Event Reporting Program

The February 2009 posting includes 46 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/feb09_quickview.htm

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/feb09.htm

The following 10 drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Fludara, Novantrone, Furadantin, Heparin Sodium, Implanon, Luvox, Prograf, Toprol XL, Tracleer, and Zerit


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