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U.S. Department of Health and Human Services

Safety

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February 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
Fludara (fludarabine phosphate), 50 milligrams, for intravenous injection X  
 X
 X
 
Novantrone (mitoxantrone HCl) Injection X  
 X
   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Furadantin (nitrofurantoin) Oral Suspension   X X      
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Heparin Sodium in 5% Dextrose Injection
Heparin Sodium in 0.9% Sodium Chloride Injection
    X X X  
Implanon (etonogestrel implant) 68 mg     X      

Luvox (fluvoxamine maleate) Tablets

Luvox CR (fluvoxamine maleate) Extended-release Capsules

    X      

Prograf (tacrolimus) Capsules, 0.5 mg, 1 mg, and 5 mg

Prograf (tacrolimus) Injection, 5 mg/ml

    X X
 
Toprol XL (metoprolol succinate) 25 mg, 50 mg, 100 mg, and 200 mg Extended Release Tablets     X      
Tracleer (bosentan) 62.5 and 125 mg Tablets     X  
MG

Zerit (stavudine) Capsules, 15 mg, 20 mg, 30 mg and 40 mg

Zerit (stavudine) Powder for Oral Solution, 1mg/mL

    X  
PPI
(Click on drug name to go to detailed view) BW C W P AR PPI/MG

Altace (ramipril) 1.25, 2.5, 5, and 10 Capsules

Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets

      X    
Amaryl (glimepiride) Tablets       X    
Capozide (captopril/hydrochlorothiazide) 25/15, 50/15, 25/25, 50/25 mg Tablets       X    
Casodex (bicalutamide) Tablets       X
 
Comtan (entacapone) Tablets       X    

Monopril (fosinopril sodium) 10, 20, and 40 mg Tablets

Monopril HCT (fosinopril/hydrochlorothiazide) 20/12.5mg and 10/12.5mg Tablets 

      X    
Noxafil (posaconazole) Oral Suspension, 40mg/mL       X   PPI
Revlimid (lenalidomide) Capsules       X    
Roxicodone (Oxycodone Hydrochloride) Tablets USP       X    
Stalevo (levodopa/carbidopa/entacapone) Tablets 200/50/200 mg       X    
Symmetrel (amantadine hydrochloride) Syrup and Tablets       X
 
Tasmar (tolcapone) Tablets       X    
Xenical (orlistat) Capsules, 120 mg       X
PPI

Zantac 150/300 (ranitidine hydrochloride) Tablets

Zantac (ranitidine hydrochloride) Syrup, USP

Zantac 25/150 (ranitidine hydrochloride) EFFERdose Tablets and 150 (ranitidine hydrochloride effervescent) Granules

Zantac (ranitidine hydrochloride) Injection and Injection Bulk Pharmacy Pack

Zantac (ranitidine hydrochloride) Injection Premixed

      X
 

Zithromax (azithromycin) 200 mg Tablet

Zithromax (azithromycin) 500 mg Tablet

Zithromax (azithromycin) IV

      X    
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Arthrotec (diclofenac sodium and misoprostol) Tablets         X  
Baraclude (entecavir) tablets and oral solution        
X
 
Cataflam (diclofenac potassium immediate-release tablets)        
X
 

Cedax (ceftibuten capsules) 400 mg

Cedax (ceftibuten for oral suspension) 18 mg/mL

       
X
 

Emend (aprepitant) capsules 40 mg, 80 mg, and 125 mg

Emend (fosaprepitant dimeglumine) for Injection, 115 mg/mL

       
X
PPI

Voltaren (diclofenac sodium enteric-coated tablets)

Voltaren-XR (diclofenac sodium extended-release tablets)

        X