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

Accutane (isotretinoin capsules) X    X  
Mobic (meloxicam) Tablets and Oral Suspension X X X  X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Adderall (mixed salts of a single-entity amphetamine product) Tablets    X X   X
FazaClo (clozapine, USP) Orally Disintegrating Tablets  

X

X    

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection

  X X    
Premarin (conjugated estrogens, USP) for Injection   X X X X
Premarin (conjugated estrogens) Vaginal Cream   X X X X
Risperdal Consta  (risperidone) Long-Acting Injection   X X    

Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-Tab (risperidone) Orally Disintegrating Tablets

  X X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
AndroGel (testosterone gel) 1%      X X X
Dianeal Low Calcium Peritoneal Dialysis Solution in Ambu-Flex III Container     X X  
Dianeal Low Calcium Peritoneal Dialysis Solution UltraBag System     X X  
Dianeal PD-1 Peritoneal Dialysis Solution in Ambu-Flex III Container     X X  
Dianeal PD-2 Peritoneal Dialysis Solution Ambu-Flex III Plastic Container     X X  
Dianeal all PD-2 Peritoneal Dialysis Solution UltraBag System     X X  
Diovan (valsartan) Tablets     X X X
Nubain (nalbuphine HCl) Injection     X   X
Relafen (nabumetone) Tablets     X X  
Ventavis (iloprost) Inhalation Solution     X X X
Zocor (simvastatin) Tablets     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aldara (imiquimod) Cream, 5%       X  X
Augmentin (amoxicillin/clavulanate potassium) Tablets       X  
Chloromycetin Sodium Succinate (chloramphenicol sodium succinate for injection, USP)       X  
Compazine (prochlorperazine) Tablets       X  
Copegus (ribavirin, USP) Tablets       X X
Cordarone (amiodarone HCl) Tablets       X  X
Cosmegen (dactinomycin for Injection) for Injection [Actinomycin D]       X  X
5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose injection, Type 1, USP) in Aviva Plastic Container       X  
5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in Aviva Plastic Container       X  
Dextrose and Sodium Chloride Injection, USP in Aviva Plastic Container       X  
Diuril (chlorothiazide) Oral Suspension       X  
Lactated Ringer's Injection, USP in Aviva Plastic Container       X  
Lactated Ringer's and 5% Dextrose Injection, USP in Aviva Plastic Container       X  
Lexxel (enalapril maleate-felodipine ER) Tablets       X  
Micro-K LS Packets (potassium chloride) Extended Release Formulation for Liquid Suspension       X  
Osmitrol Injection (mannitol injection, USP) in Aviva Plastic Container       X  
Pentetate Calcium Trisodium Injection       X  
Penetrate Zinc Trisodium       X  
Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container       X  
Plasma-Lyte 56 Injection (Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container       X  
Plasma-Lyte 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in Aviva Plastic Container       X  
Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container       X  
Plasma-Lyte 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in Aviva Plastic Container       X  
Plasma-Lyte M and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 2, USP) in Aviva Plastic Container       X  
Plasma-Lyte R Injection (Multiple Electrolytes Injection, Type 2, USP) in Aviva Plastic Container       X  
Potassium Chloride in 5% Dextrose Injection, USP in Aviva Plastic Container       X  
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP in Aviva Plastic Container       X  
Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection, USP in Aviva Plastic Container       X  
Potassium Chloride in Sodium Chloride Injection, USP in Aviva Plastic Container       X  
Ringer's Injection, USP in Aviva Plastic Container       X  
Ringer's and 5% Dextrose Injection, USP in Aviva Plastic Container       X  
Sodium Chloride Injection, USP in Aviva Plastic Container       X  
3% and 5% Sodium Chloride Injection, USP in Aviva Plastic Container       X  
Sodium Lactate Injection, USP (M/6 Sodium Lactate) in Aviva Plastic Container       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Aceon (perindopril erbumine) Tablets

        X

Coreg (carvedilol) Tablets

        X

Faslodex (fulvestrant) Injection

        X

Levaquin (levofloxacin) Tablets, Oral Solution and Injection

Levaquin (levofloxacin in 5% dextrose) Injection

        X

Persantine (dipyridamole USP)  Tablets

        X

Taxotere (docetaxel) for Injection Concentrate

        X