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

Lupron (leuprolide acetate) Injection

X     X X
Myambutol (ethambutol hydrochloride) Tablets X     X X
Vancocin Hydrochloride (vancomycin injection, USP) X     X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Accolate (zafirlukast) Tablets     X X  

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

    X X X
Flonase (fluticasone propionate) Nasal Spray     X X  
Flovent (fluticasone propionate) Inhalation Aerosol     X X  
Flovent Rotadisk (fluticasone propionate inhalation powder)     X X  

Glucophage (metformin HCl tablets)

Glucophage XR (metformin HCl extended-release tablets)

    X    
Prinivil (lisinopril) Tablets      X   X
Prinzide (lisinopril-hydrochlorothiazide) Tablets     X   X
Reyataz (atazanavir sulfate) Capsules     X X  

Suprax (cefixime) Tablets

Suprax (cefixime) Oral Suspension

    X X X
TrophAmine (amino acid injections)     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aldara (imiquimod) Cream       X X

Avelox (moxifloxacin hydrochloride) Tablets

Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)

      X  

Ceclor (cefaclor pulvules)

Ceclor (cefaclor for oral suspension)

      X X
Cortisporin (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment, USP) Ophthalmic Ointment Sterile       X  
Cozaar (losartan potassium tablets)       X X
Desyrel (trazodone hydrochloride)  Tablets       X  
E.E.S. (erythromycin ethylsuccinate)       X  
Effexor (venlafaxine hydrochloride) Tablets       X X
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules       X X
EryPed (erythromycin ethylsuccinate, USP)       X  

Eskalith (lithium carbonate) Capsules

Eskalith CR (lithium carbonate) Controlled-Release Tablets

      X  
Flagyl 375 (metronidazole capsules)       X  
Flagyl (metronidazole tablets)       X  
Flagyl  ER (metronidazole extended release tablets)       X  
Floxin (ofloxacin tablets)       X  
Glucovance (glyburide and metformin HCl tablets)       X  

Levaquin (levofloxacin) Tablets and Injection

Levaquin (levofloxacin in 5% dextrose) Injection

      X  
Lopid (gemfibrozil tablets, USP)       X  
Lotensin (benazepril HCl) Tablets       X X
Macrodantin (nitrofurantoin macrocrystals) Capsules       X  
Maxaquin (lomefloxacin hydrochloride tablets)       X  
Nasacort AQ (triamcinolone acetonide) Nasal Spray       X  
NovoLog (insulin aspart [rDNA origin] injection)       X  
Oxacillin Injection, USP       X  
PCE (erythromycin particles in tablets) Dispertab Tablets       X  
Periostat (doxycycline hyclate tablets)       X  
Prometrium (progesterone, USP) Capsules       X  
Protonix I.V. (pantoprazole sodium) for Injection       X  
Romazicon (flumazenil) Injection       X X
3% Sorbitol Urologic Irrigation Solution       X  
Spectracef (cefditoren pivoxil) Tablets       X X
Tofranil-PM (imipramine pamoate) Capsules       X  
Ultiva (remifentanil hydrochloride) for Injection       X X
Vancocin (vancomycin hydrochloride) Pulvules       X  

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Vibramycin Hyclate (doxycycline hyclate) Capsules

Vibramycin Calcium (doxycycline calcium) Oral Suspension Syrup

Vibra-Tabs (doxycycline hyclate) Film Coated Tablets

      X  

Viracept (nelfinavir mesylate) Tablets and Oral Powder

      X X
Zestril (lisinopril) Tablets       X  
Zithromax (azithromycin) Capsules, Tablets, and for Oral Suspension       X  

Zyprexa (olanzapine tablets)

Zyprexa Zydis (olanzapine orally disintegrating tablets)

Zyprexa IntraMuscular (olanzapine for injection)

      X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Arava (leflunomide) Tablets         X
Aredia (pamidronate disodium for injection) for Intravenous Infusion         X
Cancidas (caspofungin acetate) for Injection         X
GlucaGen (glucagon [rDNA origin] for injection)         X
Micardis (telmisartan) Tablets         X
Protonix (pantoprazole sodium) Delayed-Release Tablets         X
Rocephin (ceftriaxone sodium) for Injection         X
Thalomid (thalidomide) Capsules         X
Thyrogen (thyrotropin alfa for injection)         X

Vioxx (rofecoxib tablets and oral suspension)

        X
Zometa (zoledronic acid) Injection         X
Zyrtec (cetirizine hydrochloride) Tablets and Syrup         X
Zyrtec-D 12 Hour (cetirizine hydrochloride 5mg and pseudoephedrine hydrochloride 120mg) Extended Release Tablets         X