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U.S. Department of Health and Human Services

Safety

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August 2009

Drug 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
DexFerrum (iron dextran) 50 mg/mL injection X     X    
INFeD (iron dextran) 50 mg elemental iron/mL injection
X
    X    
Tasigna (nilotinib) capsules
X
  X X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arixtra (fondaparinux sodium) injection     X X X  
Flagyl (metronidazole) 500 mg I.V. injection RTU (in plastic container)     X   X  
Inomax (nitric oxide) for Inhalation     X X    
Lariam (mefloquine hydrochloride) 250 mg tablets     X X X  
Letairis (ambrisentan) 5 and 10 mg tablets     X X X MG
Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) tablets     X      
Merrem (meropenem) I.V. for injection     X X    
Primaxin (imipenem and cilastatin) IM injectable suspension     X X    
Pristiq (desvenlafaxine) extended-release tablets     X X X  
Tobramycin 1.2 gram/50mL vial for injection     X X    
Zoladex (goserelin acetate) implant     X X X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accolate (zafirlukast) tablets       X X  

Diabinese (chlorpropamide) tablets

*sulfonylurea agent change

      X    

Geodon (ziprasidone) 10 mg/mL oral suspension 

*labeling for the entire class of antipsychotic drugs

      X    

Glucotrol and Glucotrol XL (glipizide) tablets

*sulfonylurea agent change

      X    

Glynase (micronized glyburide) tablets

*sulfonylurea agent change

      X    

Metaglip (glipizide/metformin HCl fixed-dose combination) tablets

*sulfonylurea agent change

      X    
Micardis (telmisartan) tablets and Micardis HCT (telmisartan/HCTZ) tablets       X X  

Micronase (glyburide) tablets

*sulfonylurea agent change

      X    
Nizoral (ketoconazole) 2% shampoo       X X  
Serostim/Zorbtive (somatropin [rDNA origin] for injection)       X    
Singulair (montelukast sodium) tablets, chewable tablets and oral granules       X X PPI
Symbyax (olanzapine and fluoxetine hydrochloride) capsules       X    
Ventavis (iloprost) 10 mcg/mL inhalation solution       X    
Zyflo (zileuton) tablets and Zyflo CR (zileuton)  extended-release tablets       X X  

Zyprexa (olanzapine) tablets, orally disintegrating tablets and IM injection

*labeling for the entire class of antipsychotic drugs

      X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Biaxin (clarithromycin) filmtabs, granules, and XL filmtabs        
X
 
Dipentum (olsalazine sodium) 250 mg capsules        
X
 

Orencia (abatacept) powder for injection

 

       
X
 
Zemplar (paricalcitol) 2 mcg/mL and 5 mcg/mL injection        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Nplate (romiplostim) for subcutaneous injection           REMS/MG
Tracleer (bosentan) 62.5 and 125 mg tablets           REMS/MG