February 2013 Safety Labeling Changes


The MedWatch February 2013 Safety Labeling Changes posting includes 35 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:


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


Aceon (perindopril erbumine)    
Aromasin (exemestane)  
Chantix (varenicline) 
Dextrose 5% in Lactated Ringer’s Injection  
Ellence (epirubicin hydrochloride)
FML (fluorometholone)     
FML Forte (fluorometholone) 
Intelence (etravirine) 
Kapvay (clonidine hydrochloride)   
Lexiva (fosamprenavir calcium)
Lidocaine Hydrochloride and 5% Dextrose  
Niaspan (niacin extended release)     
Prezista (darunavir)   
Prinivil (lisinopril) 
Prinzide (lisinopril hydrochlorothiazide)   
Qualaquin (quinine sulfate) 
Rifadin (rifampin) and  Rifadin IV (rifampin)           
Rifater (rifampin, isoniazid, and pyrazinamide)   
Rythmol SR (propafenone HCl)
Selzentry (maraviroc)   
Simcor (niacin ER/simvastatin)
Tricor (fenofibrate) 
Xgeva (denosumab)    
Zithromax (azithromycin)         
Zmax (azithromycin extended release)    
Zortress (everolimus)   

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