Drug Safety Labeling Changes - OCTOBER  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
Glyburide - Tablets - - -
Glyburide - Tablets - -
Lupron Depot (Leuprolide Acetate for Depot Suspension) and Lupaneta Pack (Leuprolide Acetate for Depot Suspension;Norethindrone Acetate Tablets) - -
Vigabatrin - Tablet and Powder for Oral Solution - - -
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension(albumin-bound)) - - -
Acetaminophen - Injection - -
Alvimopan Capsules -
Anakinra - for Injection - - -
Climara Estradiol Transdermal System and Climara Pro (estradiol/levonorgestrel) Transdermal System -
Complera (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate) Tablets -
Crizotinib - Capsules - -
Deferasirox - Tablets, for oral suspension -
Desogestrel/Ethinyl Estradiol -
Diazepam -Tablets - - -
Doxycycline - Capsules - -
Efavirenz/Emtricitabine/Tenofovir - Tablets -
Eletriptan Hydrobomide Tablets -
Enoxaparin - Injection - -
Estradiol - Transdermal System -
Fioricet with Codeine Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules - - -
Gadobutrol - Injection -
Gadopentetate Dimeglumine Injection and Magnevist Pharmacy Bulk Package Injection - - -
Gadoxetate Disodium Injection -
Gemfibrozil - Capsules -
Glimepiride - Tablets - - -
Glipizide - Extended Release tablets - - -
Glipizide - Tablets - - -
Glipizide/Metformin Hydrochloride - fixed-dose combination Tablets - - -
Glyburide and Metformin HCl - Tablets - -
Glyburide -Tablets - -
Imatinib - Tablets - -
Juvisync (Sitagliptin Phosphate and Simvastatin) Tablets - -
Ketoconazole - 2% Shampoo - - -
Lantus( Sitagliptin phosphate and Simvastatin )Tablets - -
Memantine - Tablets - - -
Methoxsalen Sterile Solution - - -
Milnacipran Hydrochloride - Tablets -
Naltrexone - tablets
Naratriptan - Tablets -
Norethindrone/Ethinyl Estradiol -
Norethindrone/Ethinyl Estradiol -
Norgestimate/Ethinyl Estradiol -
Norgestimate/Ethinyl Estradiol -
NuvaRing (Etonogestrel/Ethinyl Estradiol Vaginal Ring) - -
Ondansetron -Oral Soluble Film - -
Orlistat - Capsules - -
Pitavastatin - Tablets - -
Quetiapine - Extended-Release Tablet - - -
Quetiapine - Tablets - - -
Quinapril - Tablets - - -
Quinapril and Hydrochlorothiazide - Tablets - - -
Raltegravir - Film-Coated Tablets and Chewable Tablets - - -
Ramipril - Capsules -
Rivastigmine - Capsules and Oral Solution
Simvastatin - Tablets - -
Solifenacin -Tablets - - -
Sorafenib - Tablets - - -
Stribild (Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Disoproxil Fumarate) fixed dose combination Tablets -
Tapentadol - Immediate-Release Tablets - - -
Telaprevir - Tablets - -
Tocilizumab Injection - -
Tranexamic acid -Tablets -
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets -
Ultracet (Tramadol HCl/ Acetaminophen) Tablets - - -
Valsartan - Capsules -
Viread Tenofovir disoproxil fumarate Tablets and Oral Powder -
Vytorin (Ezetimibe/Simvastatin)Tablets - -
Zaltrap (ziv-aflibercept) 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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