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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2005

 

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

Activella (estradiol/norethindrone acetate tablets) X  X X  X
Duramorph (morphine sulfate injection, USP) Preservative-Free  X       X
Nutropin [somatropin (rDNA origin) for injection] X    X  X  X
Nutropin AQ [somatropin (rDNA origin) injection] X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Climara (estradiol transdermal system)   X X X  
Climara Pro (estradiol/levonorgestrel transdermal system)  

X

X X  
Clozaril (clozapine) Tablets    X X    
Emtriva (emtricitabine) Capsules   X X    

Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)

Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

  X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Camptosar (irinotecan hydrochloride injection)      X    
FazaClo (clozapine, USP) Orally Disintegrating Tablets     X    
Hectorol (doxercalciferol) Injection     X X X
Keppra (levetiracetam) Tablets and Oral Solution     X X X
Mevacor (lovastatin) Tablets     X X  
Pulmicort Respules (budesonide inhalation suspension)     X X  
Raptiva (efalizumab]) for Injection, Subcutaneous     X X X

Topamax (topiramate) Tablets

Topamax (topiramate capsules) Sprinkle Capsules

    X X X
Vytorin (ezetimibe/simvastatin tablets)     X X X
Xeloda (capecitabine) Tablets     X   X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Alkeran (melphalan hydrochloride) for Injection       X  
Anzemet (dolasetron mesylate injection) Injection       X  
Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets       X X
Ceretec (Technetium Tc99m Exametazine Injection)       X  
5% Dextrose and Electrolyte No. 48 Injection        X  
5% Dextrose and Electrolyte No. 75 Injection       X  
Emend (aprepitant) Capsules       X  
Enbrel (etanercept) Subcutaneous Injection       X  
Fuzeon (enfuvirtide) for Injection       X  
Hectorol (doxercalciferol) Capsules       X  
Lexiva (fosamprenavir calcium) Tablets       X  
Niaspan (niacin extended-release tablets)       X X
Osmitrol (mannitol injection, USP) Injection       X  
Oxandrin (oxandrolone tablets, USP)       X  
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP       X  
Rapamune (sirolimus) Oral Solution and Tablets       X  
Rebif (interferon beta-1a)       X  
3% and 5% Sodium Chloride Injection, USP       X  
Sodium Iodide I 123 (Sodium Iodide I-123 Capsules)       X  
Ultane (sevoflurane) Volatile Liquid for Inhalation       X  
Venofer (iron sucrose injection, USP)       X X
Zosyn (piperacillin and tazobactam for injection)       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Accolate (zafirlukast) Tablets

        X

Alinia (nitazoxanide) Tablets and for Oral Suspension

        X

Avelox (moxifloxacin hydrochloride) Tablets

Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)

        X

Nexium (esomeprazole magnesium) Delayed-Release Capsules

        X

Singulair (montelukast sodium) Tablets, Chewable Tablets and Oral Granules

        X