Drug Safety Labeling Changes - September  2014

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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
Bimatoprost - ophthalmic solution, 0.03 percent -
Bimatoprost - Ophthalmic Solution, 0.01 percent -
Lenalidomide Capsules 2.5, 5, 10, 15, 20, and 25 mg - -
Olmesartan /Medoxomil / Amlodipine / Hydrochlorothiazide - 20/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg, and 40/10/25 mg Tablets - - -
Regadenoson - Injection -
Amlodipine/ Valsartan - 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets - - -
Amlodipine/Olmesartan Medoxomil - 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets - - -
Amlodipine/Valsartan/Hydrochlorothiazide - 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets - - -
Belatacept - - -
Bimatoprost - Ophthalmic Solution, 0.03 percent - -
Carbamazepine - Tablets, Chewable Tablets, Oral Suspension, Tegretol-XR Carbamazepine extended-release - -
Clofarabine - Injection, 1 mg/mL -
Clozapine - 25 mg and 100 mg - Tablets - - -
Dabigatran - 75 and 150 mg Capsules - - -
Dexamethasone - Intravitreal Implant 0.7 mg -
Diclofenac Sodium/Misoprostol Oral Tablets
Docetaxel - Injection Concentrate, 20 mg/1 mL, 80 mg/4 mL, and 140 mg/7 mL -
Dolasetron - Tablets, 50 mg and 100 mg - -
Doxycycline - Intravenous - - -
Doxycycline - for Oral Suspension
Doxycycline - Capsules
Doxycycline - Oral Suspension Syrup
Doxycycline - Film Coated Tablets
- - -
Edolasetron - Injection, 20 mg/mL - -
Ertapenem - Injection, 1 gm - - -
Estradiol - Transdermal System 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day -
Genotropin (somatropin [rDNA origin] for injection) - -
Granisetron - -
Lanthanum Carbonate - Chewable Tablets 500 mg, 750 mg and 1000 mg - - -
Lidocaine - Solution, 2 percent - -
Losartan - 25 mg, 50 mg, and 100 mg Tablets - - -
Losartan /Hydrochlorothiazide - 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets - -
Lumizyme (Aglucosidase Alfa) -
Megestrol Acetate - Oral Suspension, 125 mg/mL - - -
Memantine - Extended-Release Capsule, 7 mg, 14 mg, 21 mg, and 28 mg - -
MembraneBlue Trypan Blue - Ophthalmic Solution 0.15 percent - -
Nilotinib - Capsules, 150 and 200 mg - - -
Olmesartan Medoxomil - 5 mg, 20 mg, and 40 mg Tablets - - -
Olmesartan Medoxomil/ Hydrochlorothiazide - 20/12.5 mg, and 40.12.5 mg, and 40/25 mg Tablets - - -
Omalizumab - -
Ondansetron - Oral Soluble Film - -
Ondansetron - Oral Solution - -
Ondansetron - Orally Disintegrating Tablets - -
Ondansetron -Injection - -
Ondansetron -Tablets - -
Palonosetron - Injection - -
Palonosetron - Oral Capsules - -
Pegasys (Peginterferon alfa-2a) -
Phentermine and Topiramate - Extended-Release Capsules - -
Selegiline - Transdermal System 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours - - -
Sertraline Hydrochloride - 20mg/mL Oral Concentrate - - -
Simeprevir- 150 mg Capsules - - -
Somatropin [rDNA origin] Injection - -
Sucroferric Oxyhydroxide - Chewable Tablets, 500 mg Iron - - -
Triazolam - Tablets, 0.25 mg -
Valsartan - 40 mg, 80 mg, 160 mg, and 320 mg Tablets - - -
Valsartan - 80 mg and 160 mg Capsules - - -
Varenicline - Tablets; 0.5 mg and 1 mg -

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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