November 2013 Safety Labeling Changes


November 2013 Safety Labeling Changes includes 27 products with revisions to Prescribing Information

The MedWatch November 2013 Safety Labeling Changes posting includes 27 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:

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

Prevpac (Lansoprazole 30 mg delayed-release, Amoxicillin 500 mg capsules and Clarithromycin 500 mg tablets)
Zestoretic (Lisinopril/Hydrochlorothiazide)
Zestril (Lisinopril)
Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide)
Aralen (Chloroquine Phosphate) 
Jakafi (Ruxolitibib)
Lysodren (Mitotane)
Nexavar (Sorafenib)
Noxafil (Posaconazole)   
Onfi (Clobazam)     
Remicade (Infliximab)
Revlimid (Lenalidomide)
Simponi (Golimumab)
Tekamlo (Aliskiren and Amlodipine)
Tekturna (Aliskiren)
Tekturna HCT (Aliskiren and Hydrochlorothiazide)
Xalkori (Crizotinib)

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