MedWatch - February 2009 Safety-Related Drug Labeling Changes - Detailed

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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MedWatch - February 2009 Safety-Related Drug Labeling Changes - Detailed