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December 2013 Safety Labeling Changes includes 39 products with revisions to Prescribing Information
The MedWatch December 2013 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/ucm380539.htm
The following drugs had modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Iclusig (ponatinib)
Tysabri (natalizumab)
Hemabate (carboprost tromethamine)
Tikosyn (dofetilide)
Avastin (bevacizumab)
Benlysta (belimumab)
Canasa (mesalamine)
Concerta (methylphenidate HCl)
Daytrana (methylphenidate transdermal system)
Focalin (dexmethylphenidate) and Focalin XR (Dexmethylphenidate Hydrochloride)
Metadate CD (methylphenidate HCl)
Methylin (methylphenidate)
Plavix (clopidogrel bisulfate)
Quillivant XR (methylphenidate)
Ranexa (ranolazine)
Ritalin (methylphenidate hydrochloride), Ritalin SR, Ritalin LA
Taxotere (docetaxel)
Yervoy (ipilimumab)
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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