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

Ellence (epirubicin hydrochloride) Injection X   X X  
Refludan [lepirudin (rDNA)] for Injection X   X X X
Soriatane (acitretin) Capsules X X X X X
Targretin (bexarotene) Capsules X     X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Ancobon (flucytosine) Capsules     X X X

Cordarone (amiodarone hydrochloride) Tablets

 

 

X   X
Nubain (nalbuphine hydrochloride) Injection     X X X
Rapamune (sirolimus) Oral Solution and Tablets     X X X
Reglan (metoclopramide) Tablets     X X X
3.3% Sorbitol Irrigation in Plastic Container     X X X
Zestoretic (lisinopril/hydrochlorothiazide) Tablets     X X X
Zocor (simvastatin) Tablets     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Aclovate (alclometasone dipropionate) Cream and Ointment

      X  
Alkeran (melphalan hydrochloride) for Injection       X  
4% BranchAmin (branched chain amino acid) Injection in Viaflex Plastic Container       X  
Econopred (prednisolone acetate ophthalmic suspension) and

Econopred Plus (prednisolone acetate ophthalmic suspension)

      X  

Fansidar (sulfadoxine and pyrimethamine) Tablets

      X  
Flagyl 375 (metronidazole) Capsules

Flagyl ER (metronidazole) Extended Release Tablets

Flagyl (metronidazole) Tablets

      X  
Maxidex (dexamethasone ophthalmic suspension)       X  
Mobic (meloxicam) Tablets       X  
Mycostatin (nystatin lozenges) Pastilles       X  

Nebcin (tobramycin sulfate injection) Vials and Hyporets 

Nebcin (tobramycin sulfate for injection) Vials 

      X  
Ovide (malathion) Lotion       X  
Oxandrin (oxandrolone) Tablets       X  
Patanol (olopatadine hydrochloride ophthalmic solution)       X  

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection

      X  

20% Pro-Sol-sulfite-free (amino acid) Injection in Viaflex plastic container

      X  
RenAmin (amino acid) Injection       X  
Temovate E (clobetasol propionate emollient cream) Emollient

Temovate (clobetasol propionate cream) Cream and Ointment

Temovate (clobetasol propionate) Scalp Application

      X  
Topamax (topiramate) Tablets and Sprinkle Capsules       X X
Ultravist (brand of iopromide) Injection       X  
Vexol (rimexolone ophthalmic suspension)       X  
Zosyn (piperacillin sodium/tazobactam sodium)       X X
Zyrtec-D 12 Hour (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) Extended Release Tablets       X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Atacand (candesartan cilexetil) Tablets         X
Biaxin XL Filmtab  (clarithromycin) Extended-Release Tablets         X
CardioTec (Kit for the Preparation of technetium Tc99m Teboroxime)         X

Noritate (metronidazole) Cream

        X

Primacor (milrinone lactate) Injection

Primacor (milrinone lactate) in 5% Dextrose Injection

        X
Zagam (sparfloxacin) Tablets         X