Drug Safety Labeling Changes - July  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
Mometasone Furoate and Formoterol Fumarate - Inhalation Aerosol -
Sulfasalazine - Delayed Release tablets, USP -
Amlodipine and Olmesartan -Tablets - - -
Anagrelide - Capsules - -
Aripiprazole - Tablets, Oral Solution, Orally Disintegrating Tablets, and Injectable Formulation - - -
Asparaginase -
Bactrim and Bactrim DS Tablets -
Clozapine - Oral Tablets - - -
Denosumab -
Depacon (valproate sodium) Injection -
Depakote ER (Extended Release) Tablets -
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules) -
Divalproex sodium Delayed Release -
Doxycycline - Capsules - - -
Ertapenem - Injection, 1 gm - - -
Fluoxetine - Delayed Release Capsules - -
Fluoxetine - Tablets
Gadobenate- Dimeglumine - Injection and MultiHance Multipack Gadobenate Dimeglumine Injection - -
Guanfacine - Tablets - - -
Ketoconazole - Tablets - -
Leuprolide - for Depot Suspension -
Levetiracetam - Tablets, XR tablets, Oral Solution, Injection - - -
Mesalamine - Controlled-Release Capsules - -
Naltrexone - for extended-release injectable suspension - -
Nifedipine - Capsules - - -
Nifedipine - Tablets - - -
Olanzapine and Fluoxetine - Capsules - -
Olmesartan -
Olmesartan Medoxomil and Hydrochlorothiazide - Tablets -
Olmesartan Medoxomil/ Amlodipine/ Hydrochlorothiazide - Tablets -
Oxaliplatin - Injection - - -
Silodosin - Capsules - -
Tapentadol - Immediate Release Oral Tablets
Tenofovir - Oral Powder, 40 mg/gram - - -
Valproic acid - Capsules and Oral Solution -
Vandetanib - - -
Vemurafenib -Tablets -
Ziprasidone - Capsules, Injection and Oral Suspension - -

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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