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

XELODA (capecitabine) Tablets

X     X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

8-MOP (methoxsalen) Capsules

  X X    

COSMEGAN (dactinomycin) for Injection

 

X

     

MUSTARGEN (mechlorethamine HCl) for Injection

  X      
OXSORALEN-ULTRA (methosalen) Capsules   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
CUPRIC CHLORIDE Injection     X    

DRIXORAL Cold & Flu Extended Release

DRIXORAL Allergy Sinus Extended Release

(acetaminophen, dexbrompheniramine maleate, and pseudoephedrine sulfate extended release tablet)

    X    
ETHYOL (amifostine) for Injection     X X X
LEVULAN Kerastick (aminolevulinic acid HCl) for Topical Solution     X    
MAXIPIME (cefepime hydrochloride) for Injection     X X X
RAPAMUNE (sirolmus) Oral Solution and Tablets     X    

(Click on drug name to go to detailed view)

C
BW
W
P
AR
BLENOXANE (bleomycin sulfate)       X  
CARDIZEM (diltiazem hydrochloride) Tablets, Capsules, SR Capsules, and CD Capsules       X X
CECLOR (cefaclor) Pulvules and Oral Suspension       X  
CEFOTAN (cefotetan disodium) for Injection       X  
DILANTIN-125 (phenytoin oral suspension) Suspension       X  
HYCAMTIN (topotecan hydrochloride) for Injection       X  
LOTRISONE (clotrimazole, USP and betamethasone dipropionate, USP) Cream and Lotion       X  
NASONEX (mometasone furoate monohydrate) Nasal Spray       X  
PRIMAXIN (imipenem and cilastatin) IV and IM       X  
TAXOL (paclitaxel) Injection       X X
TEMODAR (temozolomide) Capsules       X  
TERAZOL 7 (terconazole) Vaginal Cream

TERAZOL 3 (terconazole) Vaginal Cream, Vaginal Suppositories

      X  
TESLAC (testolactone tablets)       X  
TIMOLIDE (timolol maleate-hydrochlorothiazide) Tablets       X  
TRANXENE T and SD (clorazepate dipotassium) Tablets       X  
VFEND (voriconazole) Tablets and IV for Injection       X X
VIDEX (didanosine) Chewable/Dispersible Tablets, Buffered Powder, Pediatric Powder, and Enteric Coated Tablets       X  
WESTCORT (hydrocortisone valerate cream)       X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
FOSAMAX (alendronate sodium) Tablets        

X

Gris-PEG (griseofulvin ultramicrosize) Tablets        

X

KALETRA (lopinavir/ritonavir) Capsules and Oral Solution        

X