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Drug Safety Labeling Changes - MAY 2013

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
Deferasirox - Tablets
Eplerenone - 25mg and 50mg Tablets
Gemcitabine - for injection 1g and 200 mg
Ipilimumab
Linezolid - for Oral Suspension
Linezolid - IV Injection
Linezolid - Tablets
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
Omeprazole - Delayed- Release Granules for Oral Suspension, 2.5 mg and 10 mg
Omeprazole - Delayed-Release Capsules, 10 mg, 20 mg, and 40 mg
Regorafenib -Tablets, 40 mg
Ribavirin - 200 mg Capsules and 40 mg/mL Oral Solution
Rituximab
Saxagliptin
Tolcapone - 100 mg Tablets
Tolvaptan - 15 mg, and 30 mg Tablets
Ustekinumab

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