Drug Safety Labeling Changes - March  2016

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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
Aclidinium bromide inhalation powder
Bivalirudin- Lyophilized Powder for Injection -
Brentuximab - for Injection - -
Canagliflozin - Tablets
Canagliflozin and Metformin - Tablets
Clindamycin - Capsules - - -
Clindamycin - Injection and Solution in Galaxy Plastic Containers - - -
Clonazepam -Tablets - - -
Darunavir and Cobicistat - Tablet - - -
Denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand -
Efavirenz - Capsules and Tablets - - -
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Fixed-dose Combination Tablet - - -
Emtricitabine/ Tenofovir - Tablets - -
Etonogestrel - Implant -
Etonogestrel - Implants -
Filgrastim-sndz -
Fulvestrant - Solution for Injection - -
Furosemide - Tablets, Injection - - -
Hydroxyurea - Capsules -
Lomitapide - Capsules - -
Mecasermin [rDNA origin] injection - - -
Ocriplasmin - Intravitreal Injection - - -
Oxybutynin Hydrochloride -Transdermal System - - -
Paliperidone - Extended-Release Tablets - - -
Paliperidone palmitate - Extended-Release Injectable Suspension - - -
Paliperidone palmitate -Extended-Release Injectable Suspension - - -
PLASMA-LYTE 56 and 5% Dextrose Injection - -
Riisperidone - Long Acting Injection - - -
Risperidone - Tablets, Oral Solution and Orally Disintegrating Tablets - - -
Ruxolitinib - Tablet - -
Sevelamer - Powder for Oral Suspension - -
Sevelamer - Tablets - -
Trastuzumab - Intravenous Infusion -
Ziv-Aflibercept - Injection - - -
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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