Drug Safety Labeling Changes - SEPTEMBER  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
Ofatumumab - Injection - -
Pemetrexed for Injection for intravenous use, 100 mg and 500 mg vials - - -
10% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container - -
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container - -
5% Dextrose and 0.2% Sodium Chloride Injection, USP in Plastic Container - -
5% Dextrose and 0.33% Sodium Chloride Injection, USP in Plastic Container - -
5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container - -
5% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container - -
Axitinib tablets - - -
Boceprevir - 200 mg capsules - - -
Bosutinib - Tablets, 100 mg and 500 mg - - -
Clarithromycin - Tablets, USP
Clarithromycin - for Oral Suspension, USPClarithromycin - Extended Release Tablets
- -
Clopidogrel - 75 mg Tablets -
Desflurane -
Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride Injections - -
Dolasetron Mesylate - -
Doxycycline Monohydrate for Oral Suspension
Doxycycline Hyclate Capsules, USP Capsules
Doxycycline Calcium Oral Suspension Syrup
Doxycycline HyclateTablets, USP Film Coated Tablets
- -
Doxylamine - Tablets, 25mg - - -
Estradiol/Norethindrone acetate transdermal system
Ezogabine tablets 50 mg, 200 mg, 300 mg, 400 mg - -
Filgrastim - -
Fluconazole - IV - - -
Fluconazole - Powder for Oral Suspension - - -
Fluconazole -Tablets - - -
Fondaparinux - Injection - -
Gemcitabine - Injection 38 mg/mL - -
Golytely (PEG 3350 and electrolytes) for Oral Solution, 1 Gallon and 4 Liter - -
Hydroxyprogesterone Caproate Injection - 250ml/mg - -
Insulin glulisine [rDNA origin] injection - -
Lacosamide - Injection - - - -
Lacosamide - Oral Solution - - - -
Lacosamide -Tablets -
Levalbuterol - Inhalation Aerosol - - -
Levonorgestrel-Releasing Intrauterine System - - - -
Linagliptin and Metformin Hydrochloride - Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg - -
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution) - - -
Mycophenolate mofetil - - -
Mycophenolic Acid - Delayed-Release Tablets - -
Nilotinib - capsules, 150 mg and 200 mg - -
Nitrofurantoin - 75 mg/Nitrofurantoin Macrocrystals - 25 mg Capsules - - -
Nitrofurantoin Macrocrystals Capsules - - -
Nulytely (PEG 3350 and electrolytes) for Oral Solution - -
Piperacillin / Tazobactam - for injection, USP -
Piperacillin /Tazobactam - injection in Galaxy Containers (PL 2040 Plastic) -
Plasma-Lyte 148 and Plasma-Lyte A pH 7.4 (Multiple Electrolytes, Type 1, USP) Injection
Potassium Chloride in Dextrose 5% and Sodium Chloride Injections - -
Quinapril - 5 mg, 10 mg, 20 mg, and 40 mg Tablets -
Quinapril - Hydrochlorothiazide - 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets -
Ramipril -1.25 mg, 2.5 mg, 5 mg, and 10 mg -
Rituximab - -
Sitagliptin and Metformin HCl -tablets, 50 mg/ 500 mg and 50 mg/ 1000 mg
Tacrolimus - Capsules, 0.5 mg, 1 mg, and 5 mg
Tacrolimus - Injection, 5 mg/ml
-
Terconazole - Vaginal Cream, 0.4% - -
Terconazole - Vaginal Suppositories, 80 mg - -
Terconazole- Vaginal Cream, 0.8% - -
Testosterone Gel - - - -
Tigecycline - for Injection -
Tobramycin inhalation solution, USP 300mg/5mL - -
Treprostinil - 20 mg, 50 mg, 100 mg, and 200 mg for Injection -
Trimethoprim and Sulfamethoxazole - Tablets
Zoledronic Acid - Injection, 4 mg/100 mL single-use ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate - -

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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