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

Advair Diskus (fluticasone propionate and salmeterol inhalation powder) X X X X X
Alora (estradiol transdermal system) X X X X X
Daraprim (pyrimethamine) Tablets X     X  X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Actos (pioglitazone HCl) Tablets     X X X
Cuprimine (penicillamine capsules)     X X X
DDAVP Injection (desmopressin acetate)     X X  
DDAVP Nasal Spray (desmopressin acetate)     X X  
DDAVP Rhinal Tube (desmopressin acetate)     X X  
DDAVP Tablets (desmopressin acetate)     X X  
ReoPro (abciximab)     X X X
Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-TAB (risperidone) Orally Disintegrating Tablets

    X   X
Symmetrel (amantadine HCl) Syrup and Tablets     X X X
Tenormin (atenolol) I.V. Injection     X X  
Tenormin (atenolol) Tablets     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Anadrol-50 (oxymetholone) Tablets       X  
Cortisporin Ointment (neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone ointment, USP)       X  
Cylert (pemoline) Tablets and Chewable Tablets       X  

DMSA (Kit for preparation of Tc99m Succimer for Injection)

      X  

Drisdol (ergocalciferol, USP) Capsules

      X  
Epivir (lamivudine) Tablets and Oral Solution       X  
Epivir-HBV (lamivudine) Tablets and Oral Solution       X  
Leukeran (chlorambucil) Tablets       X  
Lupron (leuprolide acetate) Injection       X  

Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection)

      X  
Tussionex Pennkinetic (hydrocodone polistirex/chlorpheniramine polistirex)       X  
Winstrol (stanozolol) Tablets       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
OxyContin (oxycodone HCl) Controlled-Release Tablets         X
Protonix I.V. (pantoprazole sodium) for Injection         X