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

 

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Altocor (lovastatin) Extended-Release Tablets     X X X
AndroGel (testosterone gel)     X

X

 
Peganone (ethotoin) Tablets     X X X

Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-TAB (risperidone) Orally Disintegrating Tablets

    X    
Sporanox (itraconazole) Oral Solution     X    
Zocor (simvastatin) Tablets     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Caverject (alprostadil) Sterile Powder

Caverject Injection (alprostadil injection) Aqueous

Caverject Impulse (alprostadil for injection)

      X  
Coreg (carvedilol) Tablets       X

X

Fosamax (alendronate sodium) Tablets and Oral Solution       X

X

Ganite (gallium nitrate injection)       X

X

Hyzaar (losartan potassium/hydrochlorothiazide) Tablets       X

X

Lupron Depot 7.5 mg (leuprolide acetate for depot suspension)       X  
Lupron Depot - 3 Month 22.5 mg (leuprolide acetate for depot suspension)       X

X

Lupron Depot - 4 Month 30 mg (leuprolide acetate for depot suspension)

      X

X

Meridia (sibutramine hydrochloride monohydrate) Capsules       X

X

Norvir (ritonavir) Soft-Gelatin Capsules and Oral Solution       X

X

Plavix (clopidogrel bisulfate)

      X

X

Pravachol (pravastatin sodium) Tablets       X  
Proscar (finasteride) Tablets       X

X

Pulmicort Respules (budesnonide inhalation suspension)

      X  
Pulmicort Turbuhaler (budesonide inhalation powder)       X  
Reminyl (galantamine hydrobromide) Tablets and Oral Solution       X

X

Rhinocort Aqua (budesonide) Nasal Spray        X  
Sinequan (doxepin hydrochloride) Capsules and Oral Concentrate       X  
Symmetrel (amantadine hydrochloride) Tablets and Syrup       X  
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate       X

 X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Azmacort (triamcinolone acetonide) Inhalation Aerosol         X
Glucotrol XL (glipizide) Extended Release Tablets         X

Trental (pentoxifylline) Tablets

        X