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U.S. Department of Health and Human Services

Safety

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July 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
Sutent (sunitinib malate) capsules X  XX X 
Viramune (nevirapine) tablets and oral suspension
X
  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Duraclon (clonidine hydrochloride) injection  X   
Humatrope (somatropin [rDNA origin]) for injection  X X 
Imitrex (sumatriptan) injection, nasal spray and tablets  X  
Omeprazole 20 mg delayed-release tablets  X   
Percodan (oxycodone HCl and aspirin) tablets  X   
Rapamune (sirolimus) oral solution and tablets  X 
Relistor (methylnaltrexone bromide) subcutaneous injection  XX PCI 
Relpax (eletriptan hydrobromide) tablets  X  
Strattera (atomoxetine hydrochloride) capsule  XXX 

Tygacil (tigecycline) for injection

  XX 
Vesicare (solifenacin succinate) tablet   XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accolate (zafirlukast) tablets   X X 
Priftin(rifapentine) tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Creon (pancrelipase) delayed-release capsules    
X
 
Pristiq (desvenlafaxine) extended-release tablets    
X
 
Sporanox (itraconazole) oral solution and capsules    
X
 PPI
Sprycel (dasatinib) tablets    
X
 
Twynsta (telmisartan/amlodipine) tablets    X