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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2004

 

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

Fansidar (sulfadoxine and pyrimethamine) Tablets X     X X
Methadone Hydrochloride Injection X X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Advil Liqui-Gels (200mg ibuprofen)

Advil Migraine (200mg ibuprofen) Capsules

    X    
Dextrose Injections     X X  
Mavik (trandolapril) Tablets     X    
Zometa (zoledronic acid) Injection     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Actonel (risedronate sodium) Tablets       X  
Didronel (etidronate disodium) Tablets       X  
Doryx (coated doxycycline hyclate pellets)       X  
Edecrin (ethacrynic acid) Tablets

Intravenous Sodium Edecrin (ethacrynate sodium)

      X  
Eryc (erythromycin base) Delayed-Release Capsules       X  
Fosamax (alendronate sodium) Tablets

Fosamax (alendronate sodium) Oral Solution

      X  
Glucagon for Injection (rDNA origin)       X  
Hydrea (hydroxyurea capsules)       X  
Intal (cromolyn sodium inhalation aerosal) Inhaler       X  
Intal (cromolyn sodium inhalation solution) Nebulizer Solution       X  
Manganese Chloride Injection       X  
Mephyton (phytonadione) Tablets       X  
Mexitil (mexiletine hydrochloride) Capsules       X X
Mustargen (mechlorethamine HCl for Injection)       X  

Neoral Soft Gelatin Capsules (cyclosporine capsules)

Neoral Oral Solution (cyclosporine oral solution) Modified

      X  
Pediazole (erythromycin ethylsuccinate and sulfisoxazol acetyl for oral suspension) Oral Suspension       X  
Renagel (sevelamer hydrochloride) Tablets  and Capsules       X X

Sandimmune (cyclosporine injection) Injection

Sandimmune (cyclosporine oral solution) Oral Solution

Sandimmune (cyclosporine soft gelatin capsules) Soft Gelatin Capsules

      X  
Semprex-D (acrivastine and pseudoephedrine) Capsules       X  
Stromectal  (ivermectin) Tablets       X X
Tilade (nedocromil sodium) Inhaler       X  
Vfend I.V. (voriconazole) for Injection

Vfend (voriconazole) Tablets and Oral Suspension

      X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Agenerase Capsules and Oral Solution

        X

Pletal (cilostazol) Tablets

        X