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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2004

 

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

Canasa (mesalamine) Suppository X        
Humatrope (somatropin [rDNA origin] for Injection) X   X    
NegGram (nalidixic acid) Caplets X   X X X
NegGram (nalidixic acid) Oral Suspension X   X X X
Nitrolingual Pumpspray (nitroglycerin lingual spray) X   X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)   X X    
Combivir (lamivudine/zidovudine) Tablets  

X

  X  
Epivir (lamivudine) Tablets and Oral Solution   X   X  
Epivir-HBV (lamivudine) Tablets and Oral Solution   X   X  
Forteo [teriparatide (rDNA origin)] Injection   X X   X
Serevent Diskus (salmeterol xinafoate inhalation powder)   X X    
Serevent Inhalation Aerosol (salmeterol xinafoate)   X X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Factive (gemifloxacin mesylate) Tablets     X X  
Floxin (ofloxacin tablets) Tablets     X X  
Infant's Advil (50 mg ibuprofen per 1.25 ml) oral suspension)     X    
Levaquin (levofloxacin) Tablets and Injection     X X X
Orudis KT (12.5 mg ketoprofen) Tablets     X    
Sarafem (fluoxetine hydrochloride) Pulvules     X X  

Tequin (gatifloxacin) Injection and Tablets

Tequin (gatifloxacin in 5% dextrose) Injection

    X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Abilify (aripiprazole) Tablets       X X
Actiq (oral transmucosal fentanyl citrate)       X X
Aldomet (methyldopa) Tablets       X  
Anafranil (clomipramine hydrochloride) Capsules       X X
Aromasin (exemestane tablets)       X  
Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets       X  
Avodart (dutasteride) Soft-Gelatin Capsules       X X

Claforan Sterile (cefotaxime for injection, USP)

Claforan Injection (cefotaxime sterile)

      X  
Cordarone (amiodarone hydrochloride) Intravenous       X  
5% Dextrose in Lactated Ringer's Injection       X  
Dextrose and Sodium Chloride Injections, USP       X  
Diuril (chlorothiazide sodium) Intravenous       X  
Diuril (chlorothiazide) Oral Suspension and Tablets       X  

Erythrocin Lactobionate - IV (erythromycin lactobionate for injection, USP)

      X  
Erythrocin Lactobionate - IV (sterile erythromycin lactobionate, USP)       X  
Halog (halcinonide cream, USP)       X  
Halog-E Cream (halcinonide cream, USP)       X  
Halog Ointment (halcinonide ointment, USP)       X  
Halog Solution (halcinonide topical solution, USP)       X  
Helidac Therapy ((bismuth subsalicylate/metronidazole/tetracycline hydrochloride)       X  
Indium DTPA in 111 (pentetate indium disodium In 111)       X  

Omnicef (cefdinir) Capsules

Omnicef (cefdinir)  for Oral Suspension

      X  
0.15% Potassium Chloride in 0.9% Sodium Chloride Injection, USP          
Potassium Chloride in 5% Dextrose Injections, USP       X  
Potassium Chloride in Dextrose and Sodium Chloride Injections, USP       X  
Rocephin (ceftriaxone sodium)       X  
Rocephin (ceftriaxone sodium) for Injection       X  
Rythmol SR (propafenone hydrochloride) Extended Release Capsules       X  

Tenuate (diethylpropion hydrochloride USP) Immediate Release Tablets

Tenuate Dospan (diethylpropion hydrochloride USP) Controlled-Release Tablets

      X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Caduet (amlodipine besylate/atorvastatin calcium) Tablets         X
Cancidas (caspofungin acetate) for Injection         X
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules         X
Malarone.(atovaquone and proguanil hydrochloride) Tablets

Malarone.(atovaquone and proguanil hydrochloride) Pediatric Tablets

        X