Drug Safety Labeling Changes - November  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
Adefovir dipivoxil - -
Amlodipine and Valsartan - -
Amlodipine, Valsartan and Hydrochlorothiazide - -
Boceprevir
Certolizumab -
Chlorhexidine - - -
Dabigatran - -
Desipramine - -
Febuxostat - - -
Fluvoxamine - -
Golimumab - - -
Ketorolac Trometamol Ophthalmic - -
Leflunomide - - -
Lubiprostone - - - -
Methyl Aminolevulinate Hydrochloride - - -
Misoprostol - -
Nalidixic Acid - - -
Omeprazole and Sodium Bicarbonate -
Ondansetron - -
Oxybutynin Hydrochloride - - -
Pazopanib - -
Prasugrel - -
Ritonavir - -
Romiplostim - - -
Sunitinib - - -
Telmisartan and Amlodipine - -
Tolvaptan -
Trazodone - -
Zoledronic Acid - - -

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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