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

Sonata (zaleplon) Capsules
X
 
X

 X

 

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Cordarone (amiodarone hydrochloride) Intravenous     X X X
Demerol (meperidine hydrochloride) Tablets and Syrup     X X  
Excedrin Migraine (acetaminophen, aspirin, and caffeine) Tablets     X    
Pipracil (piperacillin sodium) Injection     X X X
Prinvil (lisinopril) Tablets     X X X
Tylenol 8 Hour (acetaminophen) Extended Release Tablets (Geltabs) and Extended Release Caplets

Tylenol Arthritis Pain (acetaminophen) Extended Release Caplets

 

 

X
   
Zomig (zolmitriptan) Tablets

Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets

    X X X
Zosyn (piperacillin and tazobactam) Injection     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Alkeran (melphalan) Tablets       X  
Allegra (fexofenadine hydrochloride) Capsules and Tablets

Allegra-D (fexofenadine/pseudoephedrine) ER Tablets

      X  
Aminosyn II with Electrolytes in Dextrose Injection       X  
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension

Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets

      X X
Bacteriostatic Sodium Chloride 0.9% Injection in Plastic Vials       X  
Betadine (povidone-iodine ophthalmic solution)       X  
Betoptic S (betaxolol hydrochloride ophthalmic suspension)       X  
Cleocin T (clindamycin phosphate) Topical Solution

Cleocin T (clindamycin phosphate) Gel

Cleocin T (clindamycin phosphate) Topical Lotion

      X  
Corzide (nadolol and bendroflumethiazide) Tablets       X  
Cytadren (aminoglutethimide) Tablets       X  
Declomycin Tablets (demeclocycline hydrochloride tablets)       X  
Demser (metyrosine) Capsules       X  
Denavir (penciclovir) Cream       X  
Doxorubicin Hydrochloride for Injection

Doxorubicin Hydrochloride Injection

      X  
Duragesic (Fentanyl Transdermal System)       X  
Emadine (emedastine difumarate) Ophthlamic Solution       X  
Equagesic (meprobamate with aspirin)       X  
Exelderm (sulconazole nitrate) Cream       X  
Flonase (fluticasone propionate) Nasal Spray       X  
Gleevec (imatinib mesylate) Capsules and Tablets       X  
Hycamtin (topotecan hydrochloride) Injection       X  
Idamycin PFS (idarubicin hydrochloride) Injection       X  
Iopidine (apraclonidine hydrochloride) Ophthalmic Solution       X  
Megace (megestrol acetate) Oral Suspension       X  
Monopril (fosinopril) Tablets       X X
Navane (thiothixene) Capsules and Oral Concentrate       X X
Norcuron (vecuronium bromide) for Injection       X  
pHisoHex (hexachlorophene detergent cleanser) Topical Emulsion       X  
Psorcon E (diflorasone diacetate cream)       X  
Rebetol (ribavirin) Capsules       X  
Rilutek (riluzole) Tablets       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Amoxil (amoxicillin) Chewable Tablets

Amoxil (amoxicillin) Tablets

Amoxil (amoxicillin) for Oral Suspension

        X
Atrovent Nasal Spray (ipratropium bromide)         X
Cordarone (amiodarone hydrochloride) Tablets         X
Cuprimine (penicillamine) Capsules         X
Indocin I.V. (indomethacin) Injection         X
Lescol (fluvastatin sodium) Capsules

Lescol XL (fluvastatin sodium) Extended-Release Tablets

        X
Vioxx (rofecoxib) Tablets and Oral Solution         X