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Drug Safety Labeling Changes - July 2012

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
Clarithromycin
Colesevelam Hcl
Dantrolene
Desogestrel and Ethinyl Estradiol
Dexrazoxane
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

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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