MedWatch July 2013 Safety Labeling Changes

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The MedWatch July 2013 Safety Labeling Changes posting includes 34 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 product names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm363949.htm

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

Depakene (valproic acid) Capsules and Oral Solution
Depakote (divalproex sodium) Delayed Release
Depakote ER (Extended Release) Tablets
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)
Depacon (valproate sodium) Injection
Nizoral (ketoconazole) Tablets  
Nucynta (tapentadol) Immediate-Release (IR) Oral Tablets
Prolia (denosumab)   
Rapaflo (silodosin) Capsules
Sarafem (fluoxetine hydrochloride) Tablets
Agrylin (anagrelide hydrochloride) Capsules
Azor (amlodipine/olmesartan medoxomil) Tablets
Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)
Bactrim and Bactrim DS Tablets
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil/ hydrochlorothiazide) Tablets
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol
Elspar (asparaginase)
Geodon (ziprasidone) Capsules, Injection and Oral Suspension  
Lupron Depot (Leuprolide Acetate for Depot Suspension)
MultiHance (gadobenate dimeglumine) Injection and MultiHance Multipack (gadobenate dimeglumine) Injection  
Pentasa (mesalamine) Controlled-Release Capsules
Prozac (fluoxetine hydrochloride) Delayed Release Capsules
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules
Tribenzor (olmesartan medoxomil/ amlodipine/ hydrochlorothiazide) Tablets
Vivitrol (naltrexone for extended-release injectable suspension)
Zelboraf (vemurafenib) Tablets

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