Drug Safety Labeling Changes - October  2012

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Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions

Drug Name Sections Modified
C W P AR
Ambrisentan - -
Amlodipine and Benazepril
Atorvastatin -
Azilsartan medoxomil - -
Azilsartan Medoxomil and Chlorthalidone - -
Bevacizumab - - - -
Bortezomib - - -
Bosentan - -
Caduet (amlodipine/atorvastatin) Tablets -
Canakinumab - - - -
Certolizumab - -
Clomiphene -
Clomipramine - -
Combigan (brimonidine tartrate/timolol maleate) 0.2%/0.5% ophthalmic solution
Duloxetine -
Entecavir - - -
Esomeprazole - -
Everolimus - - -
Ezetimibe and simvastatin -
Fenofibric Acid -
Fluvastatin -
Imipramine - -
Ipilimumab - - -
Irbesartan and Hydrochlorothiazide - -
Lovastatin -
Meclizine - - - -
Milnacipran Hcl - - -
Mirtazapine - -
Naproxen and Esomeprazole Magnesium - -
Niacin Extended Release and Lovastatin -
Nortriptyline - -
Omeprazole -
Oxybutynin Hydrochloride - -
Pamidronate - - -
Pantoprazole - -
Pemetrexed - -
Pitavastatin -
Pravastatin -
Rabeprazole - -
Rituximab - - -
Rosuvastatin -
Sclerosol Intrapleural Aerosol (sterile talc) powder - - -
Simvastatin - - - -
Simvastatin and Sitagliptin -
Sitagliptin - - -
Sitagliptin-Metformin - - -
Telmisartan - -
Telmisartan and Amlodipine - -
Tocilizumab Injection - -
Topiramate - -
Valsartan - -
Valsartan and Hydrochlorothiazide - -
Vandetanib - - -

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

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