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

Flovent Rotadisk (fluticasone propionate inhalation powder)  X     X X

Genotropin (somatropin [rDNA origin] for injection)

X   X    
Orap (pimozide) Tablets X     X  
Thalomid (thalidomide) Capsules X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Accupril (quinapril hydrochloride) Tablets      X   X
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets     X   X

Aceon (perindopril erbumine) Tablets

    X    
Advil Cold and Sinus Caplets (200 mg ibuprofen and 30 mg pseudoephedrine HCl) Tablets     X    
Amerge (naratriptan) Tablets     X    
Avelox (moxifloxacin hydrochloride) Tablets and I.V.     X X X
DepoCyt (cytarabine liposome injection)     X    
Enbrel (etanercept)     X   X
Herceptin (trastuzumab)     X   X
Lotensin (benazepril HCl) Tablets     X    
Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets      X    
Micardis (telmisartan) Tablets     X X X
Monopril (fosinopril sodium) Tablets      X    
Monopril-HCT (fosinopril sodium/hydrochloride) Tablets      X    
Permax (pergolide mesylate) Tablets     X X  
Rapamune (sirolimus) Oral Solution and Tablets     X   X
Rebetol (ribavirin) Capsules and Oral Solution     X X X
Sublimaze (fentanyl citrate) Injection     X X X
Tenoretic (atenolol and chlorthalidone) Tablets     X X  
Uniretic (moexipril hydrochloride/hydrochlorothiazide) Tablets     X    
Univasc (moexipril hydrochloride) Tablets     X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Accolate (zafirlukast) Tablets       X  
Denavir (penciclovir cream)       X  X
Emcyt (estramustine phosphate sodium) Capsules       X  
Flovent (fluticasone propionate) Inhalation Aerosal       X  X
Ionamin (phentermine resin) Capsules       X  
Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Tablets       X  
Lupron Depot-PED (leuprolide acetate/depot suspension/injection)       X  
Macrobid (nitrofurantoin monohydrate/macrocrystals) Capsules       X  
Methergine (methylergonovine maleate) Tablets and Injection       X  
Prilosec (omeprazole) Delayed-Release Capsules       X X
Retrovir (zidovudine) Capsules, Syrup, and Tablets       X X
Rheumatrex (methotrexate sodium) Tablets       X
Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-TAB (risperidone) Orally Disintegrating Tablets

      X  X
Tracleer (bosentan) Tablets       X  X
Welchol (cholesevelam hydrochloride) Tablets       X  
Xenon X-133 Gas       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Floxin Otic (ofloxacin otic solution)         X
Gleevec (imatinib mesylate) Capsules         X
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules         X
Teveten (eprosartan mesylate) Tablets          X
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets         X