Drug Safety Labeling Changes - MARCH  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
Dextroamphetamine mixed salts of a single-entity amphetamine product Capsules - - -
Losartan /HCTZ Tablets - - - -
Asenapine - Sublingual Tablets - - -
Bevacizumab -
Bupropion - Sustained Release Tablets - -
Bupropion -Tablets - -
Carbamazepine - Extended Release Tablets - -
Carbamazepine - Tablets - -
Carbamazepine- Chewable Tablets - -
Carbamazepine- Oral Suspension - -
Cefipime -for Injection -
Cetuximab -
Clozapine - Oral Tablets - -
Colistimethate - - -
Degarelix - for Injection - -
Dronedarone - Tablets - - -
Galsulfase - -
Glucarpidase - - -
Humalog (insulin lispro [rDNA origin] injection) - -
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro [rDNA origin] injection) - -
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro [rDNA origin] injection) - -
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin) - - - -
Humulin N NPH (human insulin isophane suspension [rNDA origin]) - - - -
Humulin R (insulin human injection, USP [rDNA origin]) - - - -
Infliximab -
Inomax(nitric oxide) for Inhalation -
Levemir (insulin detemir [rDNA origin] injection) - -
Losartan - - - -
Meropenem - for Injection - -
Metoprolol - 50mg/100mg Tablets - -
Metoprolol - 5mg/5ml Injection - -
Naproxen - Delayed-Release Tablets - - -
Naproxen - Tablets - - -
Naproxen - Tablets - - -
Norfloxacin - Tablets - - -
Novolin 70/30 (70% NPH, human insulin isophane suspension and 30% regular human insulin [rDNA origin]) Injection - - - -
Novolin N (NPH, human insulin isophane suspension [rDNA origin]) Injection - - - -
Novolog Insulin Aspart (rDNA origin) injection) - -
NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin] injection) - -
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin] injection) - -
Panitumumab - -
Pramipexole - Extended Release Tablets - - -
Pramipexole - Tablets - - -
Propafenone - Tablets - -
Silver Sulfadiazine - Cream - - -
Sirolimus - Oral Suspension and Tablets - - -
Solifenacin - Tablets - - -
Sucralfate - Suspension - -
Sucralfate -Tablets -
Ticagrelor -Tablets -
Triptorelin Pamoate for Injectable Suspension - - -
Ziprasidone - Capsules and Oral Suspension - -
Ziprasidone - Injection - -

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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