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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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
Novantrone (mitoxantrone for injection concentrate)   X X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Mevacor (lovastatin) Tablets     X    
Nitro-Dur (nitroglycerin) Transdermal Infusion System     X    
Plavix (clopidogrel bisulfate tablets)     X X X
Prevpac (lansoprazole/amoxicillin/clarithromycin tablets)     X X X
Sustiva (efavirenz) Capsules and Tablets     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Adalat CC (nifedipine) Extended Release Tablets       X  
BenzaClin (clindamycin 1% - benzoyl peroxide 5% gel) Topical Gel       X  
Dovonex (calcipotriene cream) Cream       X  
Dovonex (calcipotriene ointment)       X  
Dovonex (calcipotriene solution) Scalp Solution       X  
Gemzar (gemcitabine HCl) for Injection       X  
Hyzaar (losartan potassium-hydrochlorothiazide tablets)       X  X
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution       X X
Trental (pentoxifylline) Tablets       X  
Zantac (ranitidine hydrochloride) Tablets and Syrup

Zantac (ranitidine hydrochloride effervescent) EFFERdose Tablets

      X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Coreg (carvedilol) Tablets

        X

Cozaar (losartan potassium tablets)

        X

Entocort EC (budesonide) Capsules

        X

Natrecor (nesiritide) for Injection

        X

Rifater (rifampin, isoniazid and pyrazinamide) Tablets

        X

Toprol-XL (metoprolol succinate) Extended Release Tablets

        X