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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2003

 

The summary view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS 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 Contraindications or Warnings sections and a link to the revised prescribing information.

Key: C=CONTRAINDICATIONS, BW=BOXED WARNING, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

 

DRUG NAME

SECTIONS MODIFIED

(Click on drug name to go to detailed view)

C

BW

W

P

AR

Artane (trihexyphenidyl Hydrochloride) Tablets and Elixir X  
X
X
X
Phenergan (promethazine HCl) Syrup and Fortis X  
X
X
X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Aralen (chloroquine phosphate tablets)

Aralen Hydrochloride (chloroquine hydrochloride injection)

   
X
X
X
AtroPen (atropine) Injection    
X
X
X
Cefotan (cefotetan disodium for injection)

Cefotan (cefotetan) Injection

   
X
   
Cognex ( Tacrine  Hydrochloride Capsules)     
X
   

Duramorph (morphine sulfate injection)

   
X
   
Infumorph (preservative-free morphine sulfate sterile solution)    
X
   
Venofer (iron sucrose injection)    
X
X
X
Zemuron (rocuronium bromide) for Injection    
X
X
X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Actos (pioglitazone HCl) Tablets       X  
Alomide (lodoxamide tromethamine ophthalmic solution)        X  

Aminosyn with Electrolytes

      X  
Aminosyn II w with Electrolytes (amino acid injection with electrolytes)       X  
Aminosyn-RF        X  
AquaMEPHYTON (phytonadione) Injection       X  
Azelex (azelaic acid cream)       X  
Capastat Sulfate (capreomycin for injection)       X  
Cardura (doxazosin mesylate) Tablets       X  
Crixivan (indinavir sulfate) Capsules       X
 X
Eurax (crotamiton) Cream and Lotion       X
 X
Halcion (triazolam) Tablets       X  
Lamprene (clofazimine) Capsules       X  
Lexxel (enalapril maleate/felodipine ER) Tablets       X  
Mephyton (phytonadione) Tablets       X  
Mintezol (thiabendazole) Chewable Tablets and Oral Suspension       X  
Nolvadex (tamoxifen citrate) Tablets       X  
Penlac Nail Lacquer (ciclopirox) Topical Solution       X  
Primaquine Phosphate Tablets       X  
Rebetol (ribavirin) Capsules        X  
Robinul (glycopyrrolate) Injectable       X  
Sustiva (efavirenz) Capsules and Tablets       X  
Tabloid (thioguanine) Tablets       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Arava (leflunomide) Tablets        
X
Buprenex (buprenorphine hydrochloride) Injectable        
X

Flovent (fluticasone propionate) Inhalation Aerosol

       
X
Flovent (fluticasone propionate inhalation powder) Rotadisk        
X
Lactated Ringer's Injection        
X
Ultane (sevoflurane) Volatile Liquid for Inhalation        
X