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

Accutane (isotretinoin) Capsules
X
X
 
X
 
Relenza (zanamivir) Oral for Inhalation
X
 
 
 
 

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Advair (fluticasone propionate/salmeterol inhalation powder) Diskus

 
X
X
X
 

Serevent (salmeterol xinafoate) Inhalation Aerosol

Serevent Diskus (salmeterol xinafoate inhalation powder)

 
X
X
X
 

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Fludara (fludarabine) for Injection   
  
X
X
X
Mykrox (metolazone) Tablets
 
 
X
 
 X
Nallpen (nafcillin sodium injection)  
 
X
X
X
3% Sorbitol Urologic Irrigation Solution  
 
X
   
X

Suprax (cefixime) Tablets and Oral Suspension

 
 
X
 

 X

Zaroxolyn (metolazone) Tablets

 
 
X
 

 X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Cleocin (clindamycin phosphate vaginal cream)  
 
 
X
 
Cytotec (misoprostol) Tablets  
 
 
X

X

Lariam (mefloquine hydrochloride) Tablets  
 
 
X
 

Lotrel (amlodipine and benazepril HCl) Capsules

 
 
 
X
 
Micro-K (potassium chloride) Extencaps Extended-Release Capsules

Micro-K 10 (potassium chloride) Extencaps Extended-Release Capsules 

 
 
 
X
 

Orudis (ketoprofen) Capsules and Extended-Release Capsules

 
 
 
X
 
Prandin (repaglinide) Tablets  
 
 
X
 
R-Gene 10 (10% arginine hydrochloride injection)  
 
 
X
 
Skelid (tiludronate disodium) Tablets  
 
 
X
 
Viadur (leuprolide acetate implant)  
 
 
X
 
Vioxx (refoecoxib) Tablets and Suspension  
 
 
X
 
Viracept (nelfinavir mesylate) Oral Powder and Tablets  
 
 
X
 

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aciphex (rabeprazole sodium) Delayed-Release Tablets
 
 
 
 
X
MS Contin (morphine sulfate controlled-release) Tablets
 
 
 
 
X
Prevacid (lansoprazole) Delayed-Release Capsules 

Prevacid (lansoprazole) for Delayed-Release Oral Suspension

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

 
 
 
 
X
Valtrex (valacyclovir hydrochloride) Caplets
 
 
 
 
X