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

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE 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 BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

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

BW

C

W

P

AR

PPI/MG
Dolophine Hydrochloride (methadone hydrochloride tablets, USP) X X X X X PPI
Herceptin (trastuzumab) X   X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Diovan (valsartan) Tablets     X   X  
Diovan HCT (valsartan and hydrochlorothiazide, USP) Combination Tablets     X      
Humira (adalimumab)     X   X  
Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP)     X X    
Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP)     X X    

Lexiva (fosamprenavir calcium) Tablets

    X X   PPI
Mirapex (pramipexole dihydrochloride) Tablets     X X X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actoplus Met (pioglitazone hydrochloride + metformin hydrochloride)       X    
Actos (pioglitazone hydrochloride) Tablets       X    
Ativan (lorazepam) Injection       X    
Flarex (fluorometholone acetate ophthalmic suspension)       X    
Humatrope (somatropin [rDNA origin] for injection)       X X  
Innohep (tinzaparin sodium) Injection       X    
Qvar (beclomethasone dipropionate HFA) Inhalation Aerosol       X    

Skelid (tiludronate disodium) Tablets

      X    

Symbyax (olanzapine and fluoxetine HCl) Capsules

      X X  
Tamiflu (oseltamivir phosphate) Oral Suspension and Capsules       X   PPI

Zyban (bupropion hydrochloride) Sustained-Release Tablet

      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

PPI/MG
Aggrenox (aspirin extended-release dipyridamole) Capsules         X  

Natrecor (nesiritide) for Injection [for Intravenous Infusion Only]

        X  

Starlix (nateglinide) Tablets

        X  
Uroxatral (alfuzosin HCl extended-release tablets)         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Videx (didanosine)

          PPI

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