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

CombiPatch (estradiol/norethindrone acetate transdermal system) X   X X  
 Efudex (fluorouracil) Topical Cream X   X    
 Percodan (oxycodone and aspirin Tablets, USP) X   X X X
 Percodan-Demi (oxycodone and aspirin Tablets, USP) X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Axert (almotriptan) Tablets     X X X
Humira (adalimumab)     X X  
Inderal (propranolol hydrochloride) LA Capsules     X   X
Inderide (propranolol hydrochloride and hydrochlorothiazide)  Tablets     X   X
ProSom (estazolam tablets)     X X  

Remeron (mirtazapine) Tablets

Remeron SolTab (mirtazapine) Orally Disintegrating Tablets

    X X  
Riomet (metformin HCl oral solution)     X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Ancef (cefazolin) Injection       X  
Camptosar Injection (irinotecan hydrochloride)       X  
Cefazolin for Injection USP and Dextrose Injection USP       X  
Cefotan (cefotetan disodium for injection)       X  
Ceftin (cefuroxime axetil) for Oral Suspension

Ceftin (cefuroxime axetil) Tablets

      X  
CefUROXime for Injection USP and Dextrose Injection USP       X  

Cefzil (cefprozil monohydrate) for Oral Suspension 

Cefzil (cefprozil monohydrate) Tablets

      X  

Claforan (cefotaxime sodium, USP) Sterile

Claforan (cefotaxime sodium) Injection

      X  
Dextrose in Sodium Chloride Injection, USP       X  
Ditropan XL (oxybutynin chloride) Extended Release Tablets       X X
Epoetin alfa for Injection       X X
Flagyl  I.V. RTU (metronidazole injection, USP)       X  
Florinef (fludrocortisone acetate tablets, USP)       X  
Hiprex (methenamine hippurate USP) Tablets       X  
Imodium A-D (loperamide HCl) Liquid

Imodium (loperamide HCl/simethicone) Caplets

Imodium Advanced (loperamide HCl/simethicone) Chewable Tablets and Caplets

      X  
INOmax (nitric oxide) for inhalation       X  
Keflex (cephalexin, USP) Pulvules       X  
Lexxel (enalapril maleate/felodipine ER) Tablets       X  
Lidocaine Hydrochloride and 5% Dextrose Injection USP       X  
Lincocin (lincomycin hydrochloride) Capsules

Lincocin (lincomycin) Injection

      X  
Maxipime (cefepime hydrochloride, USP) for Injection       X  
Mefoxin Injection (cefoxitin sodium)        X X
Merrem IV (meropenem for injection)       X  
Metronidazole Injection, USP RTU       X  

Nesacaine (chloroprocaine HCl Injection, USP)

Nesacaine-MPF (chloroprocaine HCl Injection, USP)

      X  
Nitro-Dur (nitroglycerin) Transdermal Infusion System       X  
Penicillin G Potassium Injection, USP       X  
Plendil (felodipine) Extended-Release Tablets       X  
Prograf  (tacrolimus) Capsules and Injection       X X
Potassium Chloride in 5% Dextrose and Sodium Chloride, USP in Plastic Container       X  

Prevacid (lansoprazole) Delayed-Release Capsules

Prevacid (lansoprazole) for Delayed- Release Oral Suspension

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablet

      X  
Rebetol (ribavirin, USP) Capsules and Oral Solution       X  
Rebetron Combination Therapy containing Rebetol (ribavirin, USP) Capsules and Intron A (interferon alfa-2b, recombinant) Injection       X  
Thalitone (chlorthalidone tablets, USP)       X  

Vantin (cefpodoxime proxetil) Tablets

Vantin (cefpodoxime proxetil) Oral Suspension

      X  

Viracept (nelfinavir mesylate)  Tablets

Viracept (nelfinavir mesylate) Oral Powder

      X  

Zerit (stavudine) Capsules

Zerit (stavudine) Powder for Oral Solution

      X  
Zerit XR Extended-Release, (stavudine)  Capsules       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension

Augmentin (amoxicillin/clavulanate potassium)  Chewable Tablets

        X
Augmentin ES-600 (amoxicillin/clavulanate potassium) for Oral Suspension         X
Gleevec (imatinib mesylate) Tablets         X
Mylotarg (gemtuzumab ozogamicin) for Injection         X
Temodar (temozolomide) Capsules         X