June 2012 Safety Labeling Changes

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The MedWatch June 2012 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/ucm309380.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:  

Avodart (dutasteride)
Bepreve (bepotastine besilate) 1.5% ophthalmic
CellCept (mycophenolate mofetil)
CellCept (mycophenolate mofetil hydrochloride)
Estraderm (estradiol) transdermal   
Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride)
Incivek (telaprevir) 
Jalyn (dutasteride and tamsulosin HCL)
Methergine (methylergonovine maleate) 
Myfortic (mycophenolic acid)
Noxafil (posaconazole)
Prezista (darunavir)
Prinivil (lisinopril) tablets and
Prinzide(lisinopril/hydrochlorothiazide)
Privigen Immune Globulin Intravenous (Human) 10%      
Stelara (ustekinumab)  
Strattera (atomoxetine hydrochloride)
Sustiva (efavirenz) 
Vesicare (solifenacin succinate)
Zithromax (azithromycin)

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