Drug Safety Labeling Changes - July  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
Abiraterone acetate - - -
Aldesleukin - - -
Alglucosidase - - -
Anidulafungin - -
Atomoxetine - -
Azithromycin - - -
Beclomethasone Dipropionate - -
Boceprevir - - -
Buprenorphine -
Caduet (amlodipine/atorvastatin) Tablets -
Clarithromycin
Colesevelam Hcl - - -
Dantrolene -
Desogestrel and Ethinyl Estradiol - - -
Dexrazoxane - -
Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)
Fentanyl Skin Patches -
Flurbiprofen - - -
Fulvestrant - - -
Hydromorphone -
Leuprolide - - -
Methadone -
Morphine -
Morphine Sulfate and Naltrexone Hydrochloride -
Nesiritide -
Oxycodone Hydrochloride -
Oxymorphone -
Peginterferon Alfa 2 B - - -
Pegvisomant - -
Pentoxifylline - -
Pramipexole -
Solifenacin - - -
Tacrolimus -
Tapentadol -
Thyrotropin Alfa - -
Trospium -
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets -

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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