Drug Safety Labeling Changes - February  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
Abatacept - -
Acarbose - - -
Adefovir dipivoxil - -
Aliskiren and Amlodipine - -
Aliskiren and hydrochlorothiazide -
Aliskiren and valsartan - -
Aliskiren, Amlodipine and Hydrochlorothiazide -
Ambrisentan
Amlodipine, Valsartan and Hydrochlorothiazide -
Aripiprazole - -
Atazanavir - -
Atorvastatin -
Benazepril HCl and Hydrochlorothiazide -
Cardiogen-82 (Rubidium Rb 82 Generator) - -
Conivaptan - - -
Crizotinib - -
Darunavir - -
Dexamethasone Ophthalmic -
Dextroamphetamine - - -
Diovan HCT (valsartan/hydrochlorothiazide) Tablets -
Drospirenone and Estradiol -
Drospirenone- Estradiol- Levomefolate - -
Enalapril - -
Enalapril and Hydrochlorothiazide - -
Erythromycin - - - -
Erythromycin Ethylsuccinate Granules - - -
Estradiol -
Estrogen
Ezetimibe and simvastatin -
Famciclovir -
Fluvastatin -
Indinavir -
Irbesartan and Hydrochlorothiazide -
Lapatinib - - -
Lexiva (fosamprenavir calcium) tablets and oral suspension - -
Linezolid - -
Lopinavir and Ritonavir - - -
Lopinavir and Ritonavir - -
Lovastatin
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets - -
Nelarabine - - -
Nelfinavir -
Niacin Er and Simvastatin
Norfloxacin - - -
Olmesartan - -
Olopatadine Hydrochloride -
Phendimetrazine Tartrate -
Pitavastatin -
Pravastatin Sodium -
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
Rimexolone ophthalmic - - -
Ritonavir - - -
Rituximab -
Rosuvastatin -
Saquinavir - -
Simvastatin -
Sitagliptin - - - -
Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution - - -
Tacrolimus - - -
Theophylline - - -
Tipranavir - -
Tolvaptan - - -
Valsartan - -

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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