Drug Safety Labeling Changes - December  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
Abiraterone acetate - - -
Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) Tablets - - -
Carbamazepine - - -
Cyclosporine - - -
Dabigatran - -
Desvenlafaxine -
Eculizumab - - -
Escitalopram -
Etanercept - - -
Fenofibric Acid - -
Gabapentin Enacarbil - - -
Interferon Beta-1B - - -
Ketoconazole - - -
Liraglutide [rDNA] Injection - - -
Metoprolol - - -
Milnacipran Hcl - - -
Nilotinib - - -
Olmesartan - - -
Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide Tablets - -
Oseltamivir - - -
Paroxetine -
Peginesatide -
Peginterferon Alfa 2 B - - -
Phentermine - - -
Retapamulin - -
Rilpivirine - -
Sertraline - -
Sirolimus - - - -
Sodium Oxybate - - -
Sulfasalazine - - -
Surmontil (Trimipramine Maleate) Capsules - -
Telaprevir -
Varenicline - - -
Venlafaxine - - -
Vigabatrin - - -
Vilazodone Hydrochloride -

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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