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

Travatan (travoprost ophthalmic solution)

X     X  

Zyban (bupropion hydrochloride) Sustained-Release Tablets

X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

AquaMEPHYTON (phytonadione) Injection

  X     X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Avelox (moxifloxacin hydrochloride) Tablets

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

    X X X

Demerol (meperidine hydrochloride, USP)

    X X X

Midamor (amiloride hydrochloride) Tablets

    X X  

Moduretic (amiloride hydrochloride-hydrochlorothiazide) Tablets

    X X  

Myambutol (ethambutol hydrochloride)

    X X X

Rogaine (5% minoxidil topical solution) For Men Extra Strength

    X    

Zinc Chloride Injection, USP

    X

X

 

(Click on drug name to go to detailed view)

C
BW
W
P
AR

Bactrim (sulfamethoxazole and trimethoprim) DS Tablets and Tablets, USP

      X  

Benicar (olmesartan medoxomil) Tablets

      X X

BiCNU (carmustine for injection)

      X  

Blocadren (timolol maleate) Tablets

      X X

CeeNU (lomustine) Capsules

      X  

CellCept (mycophenolate mofetil) Capsules and Tablets

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

CellCept Intravenous (mycophenolate mofetil for injection)

      X X

Lyophilized Cytoxan  (cyclophosphamide for Injection, USP)

Cytoxan Tablets (cyclophosphamide tablets, USP)

      X  

Fragmin (dalteparin sodium) Injection

      X  

Gastrocrom (cromolyn sodium, USP) Oral Concentrate

      X  

Macrobid (nitrofurantoin monohydrate/macrocrystals) Capsules

      X  

Macrodantin (nitrofurantoin macrocrystals) Capsules

      X  

Mytelase (ambenonium chloride) Capsules

     

X

 

Nexium (esomeprazole magnesium) Delayed-Release Capsules

      X  

Protonix (pantoprazole sodium) for Injection

      X  

Pulmicort Respules (budesonide inhalation suspension)

      X  

Sandimmune Injection (cyclosporine injection)

Sandimmune (cyclosporine) Oral Solution

Sandimmune (cyclosporine) Soft Gelatin Capsules

      X  

Tensilon (edrophonium chloride) Injectable Solution

      X  

Talwin NX (pentazocine hydrochloride and naloxone hydrochloride) Tablets

      X X

Zemplar (paricalcitol injection)

      X X

(Click on drug name to go to detailed view)

C
BW
W
P
AR

Oxilan (loxilan injection)

        X

Primacor (milrionone lactate) Injection

Primacor (milrinone lactate) in 5% Dextrose Injection

       

X