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.

Dec 6, 2013

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.

The "Summary Page" provides a listing of product names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm377096.htm

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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