Drug Safety Labeling Changes - February  2015

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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
Bicalutamide - Tablets - - -
Deferiprone - Tablets - - -
Oxybutynin Hydrochloride - Extended Release Tablets - -
Alendronate - Effervescent Tablets for Oral Solution - - -
Atorvastatin / Amlodipine Tablets - - -
Baclofen - Injection - -
Calcitonin-Salmon Injection - - -
Candesartan Cilexetil /Hydrochlorothiazide Tablets - - -
Candesartan -Tablets - - -
CISplatin - Injection, Sterile Aqueous Injection - - -
Degarelix - for Injection Lyophilized Powder for Injection - -
Desflurane, USP Volatile Liquid for Inhalation
Dianeal Peritoneal Dialysis Solution in Plastic Container, Low Calcium Peritoneal Dialysis Solution in ULTRABAG Plastic Container, and Dianeal PD-2 Peritoneal Dialysis Solution in ULTRABAG Plastic Container - - -
Exenatide - Injection - -
Galantamine - HBr Tablets, Oral Solution
Galantamine - HBr Extended-Release Capsules
- -
Goserelin - Implant - -
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]) - -
Insulin glulisine [rDNA origin] Injection - -
Lamivudine - Tablets and Oral Solution - -
Lantus (insulin glargine [rDNA origin]) Injection - -
Levemir (insulin detemir [rDNA origin]) Injection - -
Liraglutide [rDNA origin]) Injection - -
Minocycline - Oral Suspension - - -
Mipomersen - 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 - -
Ospemifene - Oral Tablets - -
Pentoxifylline - 400 mg Extended-Release Tablets - - -
Piroxicam - Capsules - -
Pramlintide Acetate Injection - -
Prazosin - Hydrochloride Capsules - - -
Propylthiouracil - Tablets - - -
Raltegravir - for Oral Suspension, Chewable Tablets, and Film-coated Tablets - - -
Rivastigmine - Capsule and Oral Solution -
Rivastigmine - Transdermal System -
Rotigotine -Transdermal System -
Temsirolimus - Injection - - -
Voriconazole - Tablets, for Oral Suspension, and for 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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