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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2007

 

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
Tracleer (bosentan) Film-Coated Tablets X
 
 
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Desogen (desogestrel and ethinyl estradiol) Tablets   X X X
X
PPI
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension  

X

   
X
PPI

Prevacid (lansoprazole) Delayed-Release Capsules

Prevacid (lansoprazole) for Delayed-Release Oral Suspension

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

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

BW

C

W

P

AR

PPI/MG
Bactrim (sulfamethoxale and trimethoprim DS [double strength] Tablets and Tablets, USP)     X X    
Betoptic S (betaxolol hydrochloride ophthalmic suspension) 0.25% as base, Sterile Topical Ophthalmic Drops     X X X  
Cipro I.V. (ciprofloxacin)     X X X  

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

    X X X PPI
Cipro XR (ciprofloxacin extended-release tablets)     X X X PPI
Copegus (ribavirin, USP) Tablets     X   X MG

Duricef (cefadroxil monohydrate, USP) Powder, for Suspension

Duricef (cefadroxil monohydrate, USP) Tablets and Capsules

    X X    
Floxin (ofloxacin tablets) Tablets     X X X PPI

Lescol (fluvastatin sodium) Capsules

Lescol XL (fluvastatin sodium) Extended-Release Tablets

    X      

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection

Levaquin (levofloxacin in 5% dextrose) Injection

    X X X PPI
Lyrica (pregabalin) Capsules     X X X PPI
Macrobid Capsules (nitrofurantoin monohydrate/macrocrytals)     X X    
Pegasys (peginterferon alfa-2a)     X   X MG
Pulmicort Respules (budesonide inhalation suspension)     X X X  
Timolol GFS (timolol maleate ophthalmic gel forming solution), Sterile Topical Ophthalmic Drops     X X X  
Vantin (cefpodoxime proxetil) Tablets and Oral Suspension     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adderall (mixed salts of a single-entity amphetamine product) Tablets       X
 
MG
Cardene I.V. (nicardipine hydrochloride)       X
 
 
Cystagon (cysteamine bitartrate) Capsules        X
X
PPI
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution       X
 
 
Methylin Chewable Tablets (methylphenidate HCl chewable tablets)       X
 
MG
Methylin Oral Solution (methylphenidate HCl oral solution)       X
 
MG
Omacor (omega-3-acid ethyl esters) Capsules       X X
 
Pentasa (mesalamine) Controlled-Release Capsules       X
X
 
Pulmicort Flexhaler (budesonide inhalation powder) for Oral Inhalation Only       X
 
 
Tiazac (diltiazem hydrochloride) Extended-Release Capsules       X
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Omnicef (cefdinir) Capsules

Omnicef (cefdinir) for Oral Suspension

       
X
 
Plaquenil (hydroxychloroquine sulfate, USP)        
X
 
Remicade (infliximab) for I.V. Injection        
X
 
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ansaid (flurbiprofen tablets, USP)
 
 
 
 
 
MG
Celebrex (celecoxib) Capsules
 
 
 
 
 
MG
Combunox (oxycodone HCl and ibuprofen) Tablets
 
 
 
 
 
MG
Daypro (oxaprozin caplets)          
MG

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