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

Bextra (valdecoxib) Tablets  X  X  X X X
Canasa (mesalamine, USP) Rectal Suppositories  X     X X
Cosmegen (dactinomycin for injection)  X     X
Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension) X X X X X
Naprosyn (naproxen suspension) 

Naprosyn (naproxen tablets) 

EC-Naprosyn (naproxen delayed -release tablets) 

Anaprox/Anaprox DS (naproxen sodium) Tablets 

X   X X X
Norditropin Cartridges (somatropin [rDNA origin] injection) X     X X
Phenergan (promethazine HCl) Tablets and Suppositories X   X X  
Robinul (glycopyrrolate injection, USP) Injection X   X X X
Saizen (somatropin [rDNA origin] for injection) X   X X X
Striant (testosterone buccal system) mucoadhesive X        
Tracleer (bosentan) Tablets X        

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Altace (ramipril) Capsules      X   X
AndroGel (testosterone gel) 1%     X X  
Levaquin (levofloxacin) Tablets, Oral Solution and Injection 

Levaquin (levofloxacin in 5% dextrose) Injection

    X X  
Remodulin (treprostinil sodium)  Injection     X X  
Tabloid (thioguanine) Tablets     X   X
Zyban (bupropion hydrochloride) Sustained-Release Tablets     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Arava (leflunomide) Tablets        X X
Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension        X  
Elidel (pimecrolimus) Cream 1%        X  
Iressa (gefitinib tablets)       X X
Keflex (cephalexin, USP) Pulvules        X  
Lexiva (fosamprenavir calcium) Tablets        X  
Miostat (carbachol intraocular solution, USP) 0.01%        X  
Protonix (pantoprazole) Delayed-Release Tablets        X X
Rifampin Capsules        X  
Slow-K (potassium chloride) Extended-Release Tablets        X X
Timentin (sterile ticarcillin disodium/clavulanate potassium) for Intravenous Administration        X  
Zofran (ondansetron hydrochloride) Injection

Zofran (ondansetron hydrochloride) Injection, Premixed 

      X  

Zofran (ondansetron hydrochloride) Tablets and Oral Solution

Zofran ODT (ondansetron hydrochloride) Orally Disintegrating Tablets 

      X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Benicar (olmesartan medoxomil) Tablets

        X

Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) Tablets 

         X

Cordarone (amiodarone HCl) Intravenous 

        X

Cordarone (amiodarone HCl)  Tablets

        X

Eloxatin (oxaliplatin for injection) 

       

Malarone (atovaquone and proguanil hydrochloride) Tablets

Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets

        X

Protonix I.V. (pantoprazole sodium) for Injection

        X

Stromectal (ivermectin) Tablets 

         X