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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: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm342027.htm 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)
Victrelis(boceprevir)
Xgeva (denosumab)
Zithromax (azithromycin)
Zmax (azithromycin extended release)
Zortress (everolimus)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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