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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2005

 

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

Biaxin Filmtab (clarithromycin tablets)

Biaxin XL Filmtab (clarithromycin extended-release tablets)

Biaxin Granules (clarithromycin for oral suspension, USP)

X      X  X
Diprolene (augmented betamethasone dipropionate lotion) Lotion X      X
Diprolene (augmented betamethasone dipropionate ointment) Ointment X      X X
Efudex (fluorouracil) Topical Solutions and Cream X   X    
Imodium (loperamide hydrochloride) Capsules  X    X  X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Avinza (morphine sulfate extended-release capsules)   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Epogen (epoetin alfa) for Injection      X X X
Humira (adalimumab)      X   X

Marcaine (bupivacaine hydrochloride injection, USP)

Marcaine with Epinephrine 1:200,000 (as bitartrate) (bupivacaine hydrochloride and epinephrine injection, USP)

    X    
Prinivil (lisinopril) Tablets      X    
Prinzide (lisinopril-hydrochlorothiazide) Tablets     X    
Rapamune  (sirolimus) Tablets and Oral Solution      X X X
Vytorin (ezetimibe/simvastatin tablets)     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Allegra (fexofenadine hydrochloride) Tablets        X
Aminosyn II (amino acid injection with electrolytes) with Electrolytes in Dextrose Injection with Calcium       X  
Aredia (pamidronate disodium for injection) for Intravenous Infusion        X  
Aromasin (exemestane tablets)        X

CellCept (mycophenolate mofetil capsules and tablets ) 

CellCept Oral Suspension (mycophenolate mofetil for oral suspension) 

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)  

      X  X
Detrol (tolterodine tartrate tablets)        X  
Detrol LA (tolterodine tartrate extended release capsules)         X  
Flomax (tamsulosin hydrochloride) Capsules       X  X
Gleevec (imatinib mesylate) Tablets       X  X
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution       X  
Levemir (insulin detemir [rDNA origin] injection)        X  
Nor-QD (norethindrone tablets, USP) Tablets        X  
Norvir (ritonavir capsules) Soft Gelatin and (ritonavir oral solution)       X X
Novolin R (regular, human insulin injection [recombinant DNA origin], USP)        X  
NovoLog (insulin aspart [rDNA origin] injection)        X  
Trileptal (oxcarbazepine) Tablets and Oral Suspension       X X
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets       X X
Venofer (iron sucrose injection, USP)       X
Zometa (zoledronic acid) Injection        X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Arava (leflunomide) Tablets

        X

Beconase AQ (beclomethasone dipropionate monohydrate) Nasal Spray

        X

Cubicin (daptomycin for injection) 

        X

Emend (aprepitant) Capsules

        X

Invanz (ertapenem for injection)

        X

Mylotarg (gemtuzumab ozogamicin for injection)

        X

Plavix (clopidogrel bisulfate tablets)

        X

Trelstar Depot 3.75 mg (triptorelin pamoate for injectable suspension)

        X

Trelstar LA 11.25 mg (triptorelin pamoate for injectable suspension)

        X

Zoladex (goserelin acetate implant) 3.6 mg

        X

Zoladex (goserelin acetate implant) 10.8 mg - 3 month

        X