FDA MedWatch - January 2011 Safety Labeling Changes; 43 products with revisions to Prescribing Information

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 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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