Drug Safety Labeling Changes - April  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
Romiplostim - for Injection, for Subcutaneous Use - -
Abacavir, Dolutegravir, and Lamivudine - Tablets, For Oral Use - -
Ado-trastuzumab emtansine - for Injection, for Intravenous Use - - - -
Afatinib - Tablets, for Oral Use - -
Alogliptin- Tablets, for Oral Use - -
Amiodarone-Tablets -
Bupropion - Tablets, For Oral Use - - -
Caspofungin acetate - for Injection, for Intravenous Use - - -
Certolizumab - for Injection, for Subcutaneous Use -
Chlordiazepoxide and Amitriptyline - - -
Crizotinib -Capsules, for Oral Use - - -
Dexmedetomidine - Injection and Dexmedetomidine in 0.9% Sodium Chloride Injection -
Dolutegravir - Tablets, For Oral Use - -
Doxycycline - for Oral Suspension
, Doxycycline Hyclate capsules, USP
, Doxycycline calcium oral suspension Syrup
, Doxycycline Hyclate Tablets, USP
- -
Doxycycline - Intravenous - -
Gemfibrozil -Tablets, USP -
Interferon beta-1b -for Injection, for Subcutaneous Use - -
Lenvatinib - Capsules, for Oral Use - -
Levonorgestrel-releasing intrauterine system -
Liraglutide - Injection, for Subcutaneous Use - - -
Lisinopril- Tablets, for Oral Use - - -
Ombitasvir, Paritaprevir, and Ritonavir Tablets; Dasabuvir Tablets, Co-packaged for Oral Use - - -
Oxaliplatin - Injection for Intravenous Use -
Rabeprazole - Delayed-release Tablets, for Oral Use and Delayed-release capsules - - -
Ringerís Injection, USP in VIAFLEX Plastic Container -
Saxagliptin - Tablets, for Oral Use - -
Tadalafil - Tablets, For Oral Use - -
Zoledronic acid - Injection - - -
Zonisamide - Capsules, for Oral Administration - - -

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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