The MedWatch December 2012 Safety Labeling Changes posting includes 42 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” accessible via the link below provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm332340.htm

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS and/or WARNINGS sections:

  • Altabax (Retapamulin)
  • Antara (Fenofibric Acid)
  • Celexa (Citalopram Hydrobromide)
  • Chantix (Varenicline)
  • Edurant (Rilpivirine)
  • Effexor (Venlafaxine Hydrochloride)
  • Effexor XR (Venlafaxine Hydrochloride)
  • Fibricor (Fenofibric Acid)
  • Horizant (Gabapentin Enacarbil)
  • Incivek (Telaprevir)
  • Lexapro ( Escitalopram Oxalate)
  • Omeprazole Sodium Bicarbonate and Magnesium Hydroxide
  • Omontys (Peginesatide)
  • Paxil (Paroxetine Hydrochloride)
  • Pexeva (Paroxetine Mesylate)
  • Pradaxa (Dabigatran Etexilate)
  • Pristiq (Desvenlafaxine)
  • Sabril (Vigabatrin)
  • Surmontil (Trimipramine Maleate)
  • Tamiflu (Oseltamivir Phosphate)
  • Venlafaxine
  • Viibryd (Vilazodone HCL)
  • Xyrem (Sodium Oxybate)
  • Zoloft (Sertraline Hydrochloride)
  • Zytiga (Abiraterone Acetate)

Remember that far less is known about the effects of prescribed drugs than you may believe. Never take any drugs unless they are essential. Be certain that they are indeed essential. If you are a prescriber then ask yourself honestly: How much do you really know about the drugs you prescribe? Where did you get your information? How valid and reliable is that information? How do you know this to be true?

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