Drug Safety Labeling Changes - April  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
Amlodipine Besylate and Benazepril - Capsules - -
Denosumab - -
Methylphenidate - Extended-Release Capsules - - -
Aclidinium Bromide Oral Inhalation - Powder - -
Adderall (mixed salts of a single-entity amphetamine product) Tablets - - -
Adderall XR (Dextroamphetamine mixed salts of a single entity amphetamine product) Capsules - - -
Alendronate - Tablets and Oral Solution - -
Alendronate -Effervescent Tablets for Oral Solution - -
Alendronate/ Cholecalciferol Tablets - -
Atomoxetine - Capsules - - -
Azilsartan Medoxomil /Chlorthalidone - -
Calcium Acetate - Oral Solution - - -
Cetuximab - -
Clindamycin and Benzoyl Peroxide - Gel - - -
Dexmethylphenidate - Tablets - - -
Dexmethylphenidate- Extended-Release Tablets - - -
Dextroamphetamine - Spansule Sustained Release Capsules - - -
Diclofenac /Misoprostol - Oral Tablets - -
Etidronate - Tablets - -
Flucelvax (Influenza Vaccine) -
Ibandronate - Injection - -
Ibandronate - Tablets - -
Isosorbide Dinitrate/ Hydralazine - Tablets - -
Itraconazole - Capsules and Oral Solution -
Lisdexamfetamine - Capsules - - -
Macitentan - Tablets - - -
Maraviroc - -
Methadone - Tablets - - -
Methamphetamine - Tablets - - -
Methylphenidate - Chewable Tablets - - -
Methylphenidate - Extended-Release Capsules - - -
Methylphenidate - Extended-release Oral Suspension - - -
Methylphenidate - Oral Solution - - -
Methylphenidate - Sustained-Release Tablets - - -
Methylphenidate - Tablets - - -
Methylphenidate - transdermal system - - -
Methylphenidate-Extended-release Tablets - - -
Pazopanib -Tablets -
Pomalidomide - Capsules -
Primaquine - Tablets - -
Regorafenib - Tablets - - -
Risedronate - Tablets - -
Risedronate - Delayed-Release Tablets - -
Risedronate -Tablets with Calcium Carbonate Tablets, USP - -
Saquinavir -Capsules and Tablets - - -
Sildenafil - Tablets, Single Use Vials for Injection, and Oral Suspension - - -
Simeprevir - Capsules -
Sitagliptin - Tablets - - -
Sitagliptin and Metformin - Extended Release Tablets - - -
Sitagliptin and Metformin HCl - Tablets - - -
Sunitinib Malate - -
Tadalafil - Tablets - - -
Temozolomide - for Injection - - -
Trastuzumab - -
Zoledronic Acid - 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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