Drug Safety Labeling Changes - January  2014

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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
Acetaminophen - 80 mg, 120 mg, 325 mg, and 650 mg Suppositories - - -
Amiodarone -Tablets - - -
Apixaban - 2.5 and 5 mg Tablets - - -
Azacitidine - for Injection - -
Finasteride - Tablet, 1 mg - - -
125 Phenytoin - Oral Suspension Phenytoin - Injection - -
Ambrisentan - 5 mg and 10 mg Tablets - - - -
Boceprevir - 200 mg capsules - -
Carbamazepine - Chewable Tablets,
Carbamazepine - Oral Suspension
Carbamazepine - Extended-Release Tablets
- - -
Doripenem - for Injection - -
Dronedarone - 400 mg Tablets - -
Fosphenytoin - -
Lidocaine - (4% and 8%) and Dextrose 5% Injection
Linezolid - Oral Tablets, 400 mg and 600 mg
Linezolid - IV Injection, 2 mg/mL
Linezolid - for Oral Suspension, 100 mg/5mL
- - -
Losartan -25 mg, 50 mg, and 100 mg Tablets - -
Losartan/Hydrochlorothiazide - 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets - -
Nevirapine - Extended-Release Tablets - - -
Nevirapine - Tablets and Oral Suspension - - -
Quinapril and Hydrochlorothiazide - 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets - -
Revatio 20 mg Tablets
Revatio 10 mg/12.5 mL for Injection
Revatio 10 mg/mL Powder for Oral suspension
- -
Rivaroxaban - Tablets, 10 mg - - -
Spironolctone and Hydrochlorothiazide - 25/25 mg, and 50/50 mg Tablets - -
Topiramate - Tablets (25mg, 50mg, 100mg, and 200mg)
Topiramate - Sprinkle Capsules (15mg, and 25mg)
- -

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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