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

Climara Pro (estradiol/levonorgestrel) Transdermal System) X X  X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Advil Cold & Sinus Liquigels (200 mg ibuprofen/ 30 mg pseudoephedrine HCl capsules)      X    
Children's Advil (100 mg/5 mL ibuprofen) Suspension     X    
Children's Motrin (100 mg/5 mL ibuprofen) Suspension      X    
Children's Motrin Cold (100 mg/5 mL ibuprofen and 15 mg/5 mL pseudoephedrine HCl) Suspension     X    
Emla (lidocaine 2.5% and prilocaine 2.5%) Cream     X X  
Ibuprofen Capsules 200 mg     X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Avodart (dutasteride) Soft Gelatin Capsules       X  
Clozaril (clozapine) Tablets        X  
Emtriva (emtricitabine) Capsules and Oral Solution       X  
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection        X  
Femara (letrozole tablets)       X  X
Fosamax (alendronate sodium) Tablets and Oral Solution        X X
Meridia (sibutramine hydrochloride monohydrate) Capsules       X  
Prozac (fluoxetine hydrochloride)       X  
Rowasa (mesalamine) Rectal Suspension Enema       X  X
Sarafem (fluoxetine hydrochloride)       X  
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension        X X
Velcade (bortezomib) for Injection        X X
Zovirax (acyclovir) Capsules, Tablets and Suspension       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Evoxac (cevimeline hydrochloride) Capsules

        X

Flovent HFA (fluticasone propionate) Inhalation Aerosol

        X

Prograf (tacrolimus capsules)

Prograf (tacrolimus injection) [for intravenous infusion only]

        X

Spectracef (cefditoren pivoxil) Tablets

        X

Zofran (ondansetron hydrochloride) Injection

Zofran (ondansetron hydrochloride) Injection Premixed

        X

Zofran (ondansetron hydrochloride) Tablets

Zofran ODT (ondansetron) Orally Disintegrating Tablets

Zofran (ondansetron hydrochloride) Oral Solution

        X