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

Delestrogen (estradiol valerate injection) X X X X X
Declomycin (demeclocycline hydrochloride) Tablets X   X X X
Kayexalate (sodium polystyrene sulfonate) Powder X     X X
Lidocaine HCl and 5% Dextrose Injection X        
Tazorac (tazarotene) Gel X     X X
Theophylline in 5% Dextrose Injection X        

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Viramune (nevirapine) Tablets and Oral Suspension

  X X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Carac (fluorauracil cream)     X    
Clozaril (clozapine) Tablets     X    
Lexapro (escitalopram oxalate) Tablets and Oral Solution     X X X
Prefest (estradiol and norgestimate) Tablets     X X X
ProcalAmine (3% amino acid and 3% glycerin injection with electrolytes)     X X  
Tabloid (thioguanine) Tablets     X X  
Topamax (topiramate) Tablets and Sprinkle Capsules     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)

      X  
Azmacort (triamcinolone acetonide) Inhalation Aerosol       X  
Bethine (terbutaline sulfate) Injection and Tablets       X  

Duricef (cefadroxil monohydrate) Capsules and Oral Suspension

      X  
Eryc (erythromycin delayed-release capsules)       X  
Florone (diflorasone diacetate cream)       X  
Fragmin (dalteparin sodium injection)       X X
Gleevec (imatinib mesylate) Tablets       X X
Invirase (saquinavir mesylate) Capsules       X  
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution       X  
Lupron (leuprolide acetate) Injection       X  
Malarone (atovaquone and proguanil hydrochloride) Tablets and Pediatric Tablets       X X
Myleran (busulfan) Tablets       X  
Nasacort AQ (triamcinolone acetonide) Nasal Spray       X  
Penlac Nail Lacquer (ciclopirox) Topical Solution       X  
Protonix (pantoprazole) Delayed-Release Tablets       X X
0.9% Sodium Chloride Injection       X  
Vfend (voriconazole) I.V., Tablets, and Oral Suspension       X  
Visipaque (iodixonal) Injection       X  
Xenical (orlistat) Capsules       X X
Zithromax (azithromycin) Tablets and Oral Suspension       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Nasonex (mometasone furoate monohydrate) Nasal Spray         X
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules         X