MedWatch July 2012 Safety Labeling Changes

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The MedWatch July 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm314601.htm

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

 

  • Avinza (morphine sulfate) Extended-Release Capsules
  • Butrans (buprenorphine) Transdermal System
  • Dantrium (dantrolene sodium) Oral Capsule
  • Dolophine (methadone hydrochloride) Tablets
  • Duragesic (Fentanyl Transdermal System)
  • Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules
  • Exalgo (hydromorphone HCl) Extended-Release Tablets
  • Kadian (morphine sulfate) Extended-Release Capsules
  • Methadone hydrochloride Oral Solution and Concentrate
  • MS Contin (Morphine Sulfate Controlled-Release) Tablets
  • Nucynta ER (tapentadol) Extended-Release Oral Tablets
  • Opana ER (oxymorphone hydrochloride) Extended-Release Tablets
  • Oxycontin (oxycodone hydrochloride controlled-release) Tablets
  • Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) 
  • AzaSite (azithromycin ophthalmic solution)
  •  Biaxin (clarithromycin)  
  • Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)
  • Caduet (amlodipine/atorvastatin) Tablets
  • Eraxis (anidulafungin) Powder for Injection 
  • Mirapex (pramipexole dihydrochloride)
  • Natrecor (nesiritide) for Injection
  • Prograf (tacrolimus) Capsules and Injection
  • Sanctura (trospium chloride)
  • Strattera (atomoxetine hydrochloride) capsules
  • Zinecard (dexrazoxane) for injection
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