Drug Safety Labeling Changes - MAY  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
Megestrol - Oral Suspension, 625 mg/5 ml - - -
Adalimumab -
Alfuzosin - Extended-Release tablets - - -
Anastrozole - Tablets, 1 mg - - -
Chlorhexidine - 0.75% solution - - -
Codeine Sulphate solution -
Codeine Sulphate Tablets -
Deferasirox - Tablets - -
Eplerenone - 25mg and 50mg Tablets - -
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules -
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) Capsules -
Gemcitabine - for injection 1g and 200 mg -
Ipilimumab - -
Linezolid - for Oral Suspension - - -
Linezolid - IV Injection - - -
Linezolid - Tablets - - -
Magnesium Sulfate in dextrose 5 percent injection, USP - -
Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container - -
Magnesium Sulfate Injection, USP, 50 percent - -
Methylphenidate - Extended-Release Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg - -
Methylphenidate -18 mg, 27 mg, 36 mg, and 54 mg Extended-Release Capsules - - -
Natalizumab - Injection - -
Nelfinavir - Tablets, 250 mg - - -
Nelfinavir - Tablets, 625 mg - - -
Nelfinavir Oral Powder, 50 mg/g - - -
Neoral Oral Solution (cyclosporine oral solution, USP) -
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) -
Omeprazole - Delayed- Release Granules for Oral Suspension, 2.5 mg and 10 mg - - -
Omeprazole - Delayed-Release Capsules, 10 mg, 20 mg, and 40 mg - - -
Optimark and Optimark Pharmacy Bulk Package Injection - - -
Peginterferon alfa-2b - - - -
Promethazine and Codeine Syrup -
Promethazine, Phenyl ephrine and Codeine Syrup -
Regorafenib -Tablets, 40 mg - - -
Ribavirin - 200 mg Capsules and 40 mg/mL Oral Solution - - - -
Ritalin LA 10mg, 20mg, 30mg, and 40mg Capsules - - -
Rituximab - -
Saxagliptin -
saxagliptin + metformin XR FDC tablets -
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) Tablets -
SynalgosDC (dihydrocodeine bitartrate, aspirin and caffeine) Capsules -
Tolcapone - 100 mg Tablets - -
Tolvaptan - 15 mg, and 30 mg Tablets - - - -
Ustekinumab - - -
Vivelle-Dot (estradiol transdermal system)

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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