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

Agrylin (anagrelide hydrochloride) Capsules  X   X X  
Estraderm (estradiol transdermal system) X X X X  X
Lac-Hydrin (ammonium lactate) 12% Cream  X   X  X  
Vistaril (hydroxyzine pamoate) Capsules and Oral Solution  X       X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Nolvadex (tamoxifen citrate) Tablets    X      
Prometrium (progesterone, USP) Capsules   

X

  X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Children's Advil (50 mg ibuprofen) Chewable Tablets     X    
Elitek (rasburicase)     X    
Junior Strength Advil (100 mg ibuprofen) Chewable Tablets     X    
Neulasta (pegfilgrastim)     X    
Neupogen (filgrastim)     X    
Pegasys (peginterferon alfa-2a)     X X  
Rebif (interferon beta-1a)     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Abilify (aripiprazole) Tablets and Oral Solution        X  
Aldoril (methyldopa-hydrochlorothiazide) Tablets        X  
Atacand HCT (candesartan cilexetil-hydrochlorothiazide) Tablets        X X
Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension        X  
Azactam (aztreonam injection)        X  
Azactam (aztreonam for injection, USP)        X  
Bicillin C-R and Bicillin C-R 900/300 (penicillin G benzathine and penicillin G procaine injectable suspension)        X  
Cardizem (diltiazem HCl) Injectable, Lyo-Ject Syringe and Monovial        X  
Cordarone (amiodarone HCl) Tablets        X  
Crixivan (indinavir sulfate) Capsules        X  
Emend (aprepitant) Capsules        X  
Extraneal (icodextrin) Peritoneal Dialysis Solution        X X
Fosamax (alendronate sodium) Tablets and Oral Solution       X X
Geocillin (carbenicillin indanyl sodium) Tablets       X  
K-Tab (potassium chloride) 10 mEq (750 mg) Extended-Release Tablets        X  
Lexxel (enalapril maleate-felodipine ER) Tablets       X  
Prediapred (prednisolone sodium phosphate) Oral Solution        X  
Protonix  I.V. (pantoprazole sodium) for Injection       X X
RID Mousse (0.33% pyrethrins and 4.0% piperonyl butoxide) Topical Aerosolized Foam        X  
Valtrex (valacyclovir hydrochloride) Caplets        X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Atacand (candesartan cilexetil) Tablets

         X

Mephyton (phytonadione) Tablets

         X

Mifeprex (mifepristone) Tablets

        X

Nasonex (mometasone furoate monohydrate) Nasal Spray

         X

Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%

         X