September 2010 FDA Safety Labeling Changes

November 02, 2010

In the second half of each month, the FDA publishes a list of all safety labeling changes for the previous month. The MedWatch September 2010 safety labeling changes posting includes 37 products with 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 revised safety labeling sections. Selecting a drug product name in the summary view will take you to the detailed view page, which identifies revised safety labeling sections and subsections, along with a brief summary of new or modified safety information.

The following drugs had modifications to the boxed warnings, contraindications and warnings sections: 

  • Aciphex (rabeprazole sodium)    
  • Alli (orlistat)  
  • Altabax (retapamulin) 
  • Apokyn (apomorphine hydrochloride)
  • Arava (leflunomide)
  • Casodex (bicalutamide)
  • Combunox (oxycodone HCl/ibuprofen)
  • Desferal (deferoxamine mesylate)
  • Dexilant (dexlansoprazole)
  • Faslodex (fulvestrant)   
  • Minocin (minocycline hydrochloride)  
  • Nexium (esomeprazole magnesium)
  • Nexium IV (esomeprazole sodium) 
  • Noxafil (posaconazole)
  • Prevacid (lansoprazole)
  • Prilosec (omeprazole magnesium) 
  • Protonix (pantoprazole sodium)
  • Rotarix (rotavirus vaccine, live, oral)
  • Zegerid (omeprazole/sodium bicarbonate)
  • Zegerid with magnesium hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide)
  • Zofran (ondansetron hydrochloride)

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