Drug Safety Labeling Changes - April  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
Advicor (Niacin Extended-release/Lovastatin) Tablets -
Aliskiren
Aliskiren and Amlodipine
Aliskiren and hydrochlorothiazide
Aliskiren and valsartan -
Aliskiren, Amlodipine and Hydrochlorothiazide
Boceprevir - - -
Calcitonin- Salmon - - -
Candesartan - -
Certolizumab - -
Denosumab - -
Drospirenone and Estradiol - -
Drospirenone- Estradiol- Levomefolate - -
Erlotinib - -
Estradiol -
Estrogen - -
Everolimus - -
Finasteride - - -
Histrelin acetate - - -
Iloprost - - -
Insulin Detemir -
Itraconazole -
Levofloxacin - -
Liraglutide [rDNA] Injection -
Lovastatin
Megestrol - - -
Nelfinavir -
Omeprazole and Sodium Bicarbonate - -
Palivizumab -
Paroxetine - - -
Pazopanib - -
Pegloticase - -
Perindopril - -
Ramipril - -
Repaglinide and Metformin - -
Rituximab - - -
Rotigotine - -
Somatropin -
Sunitinib -
Terbinafine - - -

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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