The MedWatch January 2011 Safety Labeling Changes posting includes 43 products

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The MedWatch January 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, 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/Safety/MedWatch/SafetyInformation/ucm240075.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.

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

Carbatrol (carbamazepine)
EES (erythromycin ethylsuccinate)
Ery-Ped (erythromycin ethylsuccinate)
PCE (erythromycin particles in tablets) Dispertab
Gelnique (oxybutynin chloride) 10% gel
Uloric (febuxostat tablets)
Zithromax (azithromycin)
Actonel (risedronate sodium)
Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP)
Atelvia (risedronate sodium)
Boniva (ibandronate sodium)
Coreg (carvedilol)
Coreg CR (carvedilol phosphate)
Cyklokapron (tranexamic acid)
Folotyn (pralatrexate)
Fosamax (alendronate sodium)
Fosamax Plus D (alendronate sodium/cholecalciferol)
Kayexalate (sodium polystyrene sulfonate)
Oxytrol (oxybutynin transdermal system)
Prilosec (omeprazole)
Prilosec (omeprazole magnesium)
Reclast (zoledronic acid)
Rituxan (rituximab)
Sanctura (trospium chloride)
Sanctura XR (trospium chloride extended release capsules)
Tasigna (nilotinib)
Tessalon (benzonatate)
Trelstar (triptorelin palmoate)
Viagra (sildenafil citrate)
Zoladex (goserelin acetate)

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