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

Fluvoxamine Maleate Tablets  X   X  X  
Norvir (ritonavir capsules) Soft Gelatin   X    X  X  
Tev-Tropin [somatropin (rDNA origin) for injection] X    X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Ellence (epirubicin hydrochloride injection)    X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Abilify (aripiprazole) Tablets and Oral Solution      X    
Crestor (rosuvastatin calcium) Tablets      X X X
Diamox Sequels (acetazolamide extended-release capsules)     X X X
Femring (estradiol acetate vaginal ring)      X    
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution     X X  
Maxaquin (lomefloxacin hydrochloride tablets)     X X X
Temodar (temozolomide) Capsules      X   X
Trileptal (oxcarbazepine) Tablets and Oral Solution     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Boniva (ibandronate sodium) Tablets       X  X
Children's Advil (100 mg/5 mL ibuprofen) Suspension       X  
Cialis (tadalafil) Tablets       X  
Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution)        X  X
Gleevec (imatinib mesylate) Tablets        X
Indocin (Indomethacin) Capsules, Oral Suspension and Suppositories        X  
Levoxyl (levothyroxine sodium, USP) Tablets        X X
Nolvadex (tamoxifen citrate) Tablets        X  
Rapamune (sirolimus) Oral Solution and Tablets       X X
Velcade (bortezomib) for Injection       X X
Vfend I.V. (voriconazole) for Injection

Vfend (voriconazole) Tablets

Vfend (voriconazole) for Oral Suspension

      X  
Vytorin (ezetimibe/simvastatin) Tablets       X  
Zetia (ezetimibe) Tablets       X X
Zofran (ondansetron hydrochloride) Injection

Zofran (ondansetron hydrochloride) Injection Premixed 

      X  X
Zosyn (piperacillin and tazobactam for injection)        X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Prilosec (omeprazole) Delayed-Release Capsules

         X

Visudyne (verteporfin for injection)

         X