Drug Safety Labeling Changes - August  2012

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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
Albuterol and Ipratropium - - -
Artemether and Lumefantrine -
Atomoxetine - -
Bactrim (Sulfamethoxazole and Trimethoprim) Tablet and - - -
Bactrim DS (Sulfamethoxazole and Trimethoprim) Double-Strength Tablet - - - -
Bupropion -
Captopril - -
Certolizumab - - -
Cladribine -
Cyclosporine -
Delavirdine - - -
Duloxetine - - -
Efavirenz - -
Emtricitabine- Rilpivirine- Tenofovir - -
Enfuvirtide - -
Etravirine - -
Felbamate - - - -
Fesoterodine Fumarate -
Gabapentin - - -
Ipratropium Bromide - -
Ivacaftor - - -
Lamotrigine - -
Linagliptin -
Lisinopril - - -
Lisinopril and Hydrochlorothiazide - - -
Lovaza (Omega-3-Acid Ethyl Esters) Capsules - -
Maraviroc - -
Mometasone Furoate and Formoterol Fumarate - - -
Moxifloxacin - -
Norelgestromin and Ethinyl Estradiol - -
Olanzapine - - - -
Olanzapine and Fluoxetine - - -
Oxaliplatin - -
Paliperidone Palmitrate -
Panitumumab Injection -
PEG-3350 and Minerals - -
Perflutren Protein-Type A Microspheres - -
Pramipexole - -
Raltegravir - -
Ranibizumab - -
Rilpivirine - -
Sevoflurane - - -
Sildenafil -
Solifenacin - - -
Sorafenib -
Tenofovir - -
Tolterodine - - -
Torasemide - - -
Trobicin (Spectinomycin) for Injectable Suspension - - -
Trospium Chloride -
Valsartan
Valsartan and Hydrochlorothiazide -
Venlafaxine - - -

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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