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U.S. Department of Health and Human Services

Safety

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May 2010

Safety Labeling Changes

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

 
         
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Parnate (tranylcypromine sulfate) tablets   X        
PrandiMet (repaglinide/metformin HCl fixed-dose combination) tablet   X X X    
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) orally disintegrating tablets   X X X X  
Selzentry (maraviroc) tablets   X X X    
Vaprisol (conivaptan) injection   X X      
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Camptosar (irinotecan HCl) injection     X X X  
Cervidil (dinoprostone) vaginal insert     X   X  
Droxia and Hydrea (hydroxyurea) capsules     X X    
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin]) injection     X X X  
Tekturna HCT (aliskiren/hydrochlorothiazide) tablets     X X    
Zyprexa (olanzapine) tablet, orally disintegrating tablet, and injection     X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Asacol (mesalamine) 400 mg and Asacol HD (mesalamine) 800 mg delayed-release tablets       X    
Prevacid (lansoprazole) delayed-release capsules and orally disintegrating tablets       X   PCI
Taxotere (docetaxel) injection concentrate       X    
Topicort (desoximetasone) ointment       X    

Wellbutrin (bupropion HCl) tablets and Wellbutrin SR (bupropion HCl) sustained-release tablets

Wellbutrin XL (bupropion HCl) extended-release tablets

      X   MG
Xenical (orlistat) capsules       X X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Invanz (ertapenem) for injection        
X
 
Invega Sustenna (paliperidone palmitate) extended-release injectable suspension        
X
 
Ixempra kit (ixabepilone) for intravenous infusion        
X
 
MS Contin (morphine sulfate) controlled-release tablets        
X
 
Zyprexa Relprevv (olanzapine) for extended release injectable suspension         X