Drug Safety Labeling Changes - NOVEMBER  2013

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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
Lisinopril -Tablets - -
Alendronate /Cholecalciferol - Tablets - -
Aliskiren - Tablets - -
Aliskiren and Amlodipine - Tablets - -
Aliskiren and Hydrochlorothiazide - Tablets - -
Aliskiren, Amlodipine and Hydrochlorothiazide - Tablets - -
Atorvastatin/Amlodipine -Tablets  - - -
Chloroquine - Tablets - -
Clobazam - Tablets and Oral Suspension - -
Crizotinib - Capsules - -
Daptomycin - for Injection - - -
Golimumab - Injection -
Infliximab - Lyophilized Concentrate for Injection - -
Lanreotide - Injection - - -
Lansoprazole - 30 mg Delayed-Release,
Amoxicillin - 500 mg Capsules and Clarithromycin - 500 mg Tablets
-
Lenalidomide - Capsules - -
Levocetirizine Dihydrochloride - Tablets and Oral Solution - - -
Lisinopril/Hydrochlorothiazide - Tablets - -
Mitotane - Tablets -
Nitrofurantoin - Oral Suspension - - -
Pazopanib - Tablets - - -
Pioglitazone - Tablet - - -
Pioglitazone and Metformin Hydrochloride - - -
Pioglitazone - Tablets - - -
Posaconazole - Delayed-release tablets and Oral Suspension - - -
Ruxolitini - Tablets - - -
Sorafenib - Tablets  - - -

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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