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U.S. Department of Health and Human Services

Safety

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November 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, PCI=PATIENT COUNSELING INFORMATION

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

BW

C

W

P

AR

PPI/MG
Actiq (fentanyl citrate) oral transmucosal
X
         

Cimzia (certolizumab pegol)

*TNF-blockers class change

X   X X X MG
Cleocin HCL (clindamycin hydrochloride) capsules X   X X    

Enbrel (etanercept)

*TNF-blockers class change

X
   X X   MG

Humira (adalimumab) injection

*TNF-blockers class change

X   X X X  
Qualaquin (quinine sulfate) 324 mg capsules X   X     MG

Remicade (infliximab) for IV injection

*TNF-blockers class change

X
  X     MG

Simponi (golimumab)

*TNF-blockers class change

X   X     MG
Tekturna (aliskiren) tablets
X
  X X X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lotensin (benazepril hydrochloride) tablets   X        
Lotensin HCT (benazepril/hydrochlorothiazide) tablets   X     X  
Norvir (ritonavir) capsule and solution   X X X    
Parnate (tranylcypromine sulfate) tablets   X        
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adenocard (adenosine) 3 mg/mL injection     X      
Adenoscan (adenosine) 3 mg/mL injection     X      
Avandaryl (rosiglitazone maleate and glimepiride) tablets     X X   MG
Byetta (exenatide) injection     X X    
Lopressor (metoprolol tartrate) tablets and ampules for injection     X X    
Plavix (clopidogrel bisulfate) 75 mg tablets     X X    
Rebetol (ribavirin) capsules and solution     X X    
Rilutek (riluzole) tablets     X X X  
Soma (carisoprodol) 250 mg and 350 mg tablets     X X   PCI
Soma Compound (carisoprodol 200 mg and aspirin 325 mg) tablets     X X   PCI
Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg) tablets     X X   PCI
Truvada (emtricitabine/tenofovir disoproxil fumarate tablets     X X X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Altace (ramipril) tablets       X    
Catapres (clonidine hydrochloride) tablets       X X  
Catapres-TTS (clonidine) trandsdermal therapeutic system       X X  
Effexor (venlafaxine HCl) tablets and Effexor XR (venlafaxine HCl) Extended-Release capsules       X    
Entereg (alvimopan) capsules       X    
Glucovance (glyburide and metformin HCl) tablets       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avelox (moxifloxacin) IV and tablets         X  
Cordarone (amiodarone HCl) 200 mg tablets         X  
Isentress (raltegravir potassium) 400 mg tablets         X PPI
Pristiq (desvenlafaxine) Extended-Release tablets         X MG
Relistor (methylnaltrexone bromide) Subcutaneous injection         X PPI
Sensipar (cinacalcet HCl) tablets         X  
Urso 250 and Urso Forte (ursodiol) tablets           X  
Vytorin (ezetimibe/simvastatin) tablets        
X
PPI
Zestoretic (lisinopril and hydrochlorothiazide) tablets         X  
Zestril (lisinopril) tablets         X  
Zometa (zoledronic acid) injection        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actoplus Met (pioglitazone HCl + metformin HCl) fixed-dose combination tablets           MG
Retrovir (zidovudine) capsules, tablets and syrup           PCI