FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website
FDA Home Page | About MedWatch | Contact MedWatch | MedWatch Partners
 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program


 
 

Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2005

 

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

Copegus (ribavirin, USP) Tablets  X    X  X  X
Duragesic (fentanyl transdermal system)  X X  X X X
Lotronex (alosetron HCl) Tablets  X X  X X  
Malarone (atovaquone and proguanil hydrochloride) Tablets

Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets

X     X X
Serostim LQ (somatropin [rDNA origin] injection)  X        

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Celexa (citalopram hydrobromide) Tablets and Oral Solution    X X X  
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules   

X

X X  
Effexor (venlafaxine hydrochloride) Tablets    X X X  
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules   X X X  
Lexapro (escitalopram oxalate) Tablets and Oral Solution   X X X  
Nardil (phenelzine sulfate tablets, USP)    X X X  
Prozac (fluoxetine hydrochloride)    X X X  
Sarafem (fluoxetine hydrochloride)   X X X  
Sinequan (doxepin HCl) Capsules and Oral Concentrate   X X X  
Symbyax (olanzapine and fluoxetine HCl capsules)   X X X  
Viramune (nevirapine) Tablets and Oral Suspension   X      
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Atacand (candesartan cilexetil) Tablets     X X X
Cancidas (caspofungin acetate) for Injection     X    
Gabitril (tiagabine hydrochloride) Tablets      X    
Minocin (minocycline for Injection) Intravenous

Minocin (minocycline hydrochloride)  Pellet-filled Capsules and Oral Suspension  

    X X X
Strattera (atomoxetine HCl)     X X  
Tenoretic (atenolol and chlorthalidone)     X X  
Tenormin (atenolol) I.V. Injection     X X  
Tenormin (atenolol) Tablets     X X  
Zantac 75 (ranitidine) Tablets     X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aredia (pamidronate disodium for injection) for Intravenous Infusion       X  
Avandia (rosiglitazone maleate) Tablets       X  X
Celebrex (celecoxib) Capsules       X  X
Ketek (telithromycin) Tablets       X  
Prandin (repaglinide) Tablets       X  X
Visicol (sodium phosphate monobasic monohydrate, USP & sodium phosphate dibasic anhydrous, USP) Tablets       X  
Zetia (ezetimibe) Tablets        X  X
Zyvox (linezolid) Tablets, Oral Suspension, and Injection        X  X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Neurontin (gabapentin) Capsules, Tablets and Oral Solution

         X

Penicillin G Potassium Injection, USP

         X