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January 2014 Drug Safety Labeling Changes includes 23 products with revisions to Prescribing Information
The MedWatch January 2014 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm384738.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Cozaar (losartan)
Hyzaar (losartan/hydrochlorothiazide)
Lidocaine Hydrochloride (4% and 8%) and Dextrose 5% Injection
Victrelis (boceprevir)
Cerebyx (fosphenytoin)
Doribax (doripenem) for Injection
FeverAll (acetaminophen)
Multaq (dronedarone hydrochloride)
Revatio
Topamax (topiramate)
Topamax (topiramate)
Vidaza (azacitidine)
Xarelto (Rivaroxaban)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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