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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2006

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING,  CONTRAINDICATIONS, 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: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

 
DRUG NAME SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Abilify (aripiprazole) Tablets and Oral Solution X     X  
Fortamet (metformin HCl extended-release tablets) X        
Tasmar (tolcapone) Tablets X     X X

Tolectin 600 (tolmetin sodium) Tablets

Tolectin DS (tolemetin sodium) Capsules

X X X X  
Wellbutrin (bupropion hydrochloride) Tablets  X   X    
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets X   X    
Wellbutrin XL (bupropion hydrochloride extended-release tablets) X   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)

BW

C

W

P

AR

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension   X X X  
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets  

X

X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Acetadote (acetylcysteine) Injection (for Intravenous Use)     X X  
Advil Allergy Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl/ 2 mg chlorpheniramine maleate) Tablets     X    
Advil Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets     X    
Advil Liqui-Gels (200 mg ibuprofen capsules)

Advil Migraine (200 mg ibuprofen) Capsules

    X    

Children's Motrin (50 mg ibuprofen) Chewable Tablets

Motrin Junior Strength (100 mg ibuprofen) Chewable Tablets

    X    
Effexor (venlafaxine hydrochloride) Tablets     X X X
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules     X X X
Junior Strength Motrin (100 mg ibuprofen) Tablets     X    
Motrin Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets     X    

Motrin IB (200 mg ibuprofen) Tablets

Motrin Migraine Pain (200 mg ibuprofen) Tablets

    X    
Motrin Infants' Drops (50 mg/1.25 mL ibuprofen oral suspension)     X    
Rituxan (rituximab)

[Diffuse large B‑cell, CD20‑positive, non-Hodgkin's lymphoma indication]

    X X X
Rituxan (rituximab)

[Rheumatoid Arthritis Indication]

    X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Astelin (azelastine hydrochloride) Nasal Spray       X X
Betaxolol hydrochloride ophthalmic solution, 0.5% as base       X  
Cardura (doxazosin mesylate) Tablets       X X
Ceredase (alglucerase injection)       X  
Cystadane (betaine anhydrous for oral solution)       X X
Famvir (famciclovir) Tablets       X X
Flovent HFA (fluticasone propionate) Inhalation Aerosol       X X
Hytrin (terazosin hydrochloride) Capsules       X X
Hytrin (terazosin hydrochloride) Tablets       X X
Lasix (furosemide) Tablets       X  
Nexium (esomeprazole magnesium) Delayed-Release Capsules       X X
Nexium  I.V. (esomeprazole sodium) for Injection       X X
Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension       X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

FazaClo (clozapine, USP) Orally Disintegrating Tablets

        X

1.5% Glycine Irrigation, USP

        X

Imitrex (sumatriptan succinate) Injection

        X

Indocin I.V. (indomethacin sodium trihydrate)

        X

Lupron (leuprolide acetate) Injection (for pediatric use)

        X

Lupron Depot-Ped (leuprolide acetate for depot suspension)

        X