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U.S. Department of Health and Human Services

Safety

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October 2008

Drug Safety Labeling Changes

 

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

Avelox (moxifloxacin hydrochloride) Tablets
 

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

X 
X
X
 
MG
Cipro I.V. (ciprofloxacin) for Intravenous Infusion
X
 
X
X
 
MG

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

X
  
X
 
X
 
MG
Cipro XR (ciprofloxacin extended-release tablets)
X
 
X
X
 
MG
Factive (gemifloxacin mesylate) Tablets
X
 
X
X
X
MG
Floxin (ofloxacin) Tablets
X
 
X
X
 
MG

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

X
 
X
X
 
MG
Noroxin (norfloxacin) Tablets
X
 
X
X
 
MG
Ontak (denileukin difttox) Solution for Intravenous Use
X
 
X
X
X
 
Raptiva (efalizumab) for Injection, Subcutaneous
X
 
X
X
X
PPI
Regranex (becaplermin) Gel 0.01 %
X
 
X
   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Apidra (insulin glulisine [rDNA origin] injection) Solution for Injection  
X
X
X
X
PPI
Norditropin Cartridges [somatropin (rDNA origin) injection], for Subcutaneous Use  

X

X
X
X
PPI
Prevacid NapraPAC 500
(lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit)
 
X
X
X
X
MG
Prezista (darunavir) Tablets 
X
X
X
X
PPI
Rozerem (ramelteon) Tablets 
X
X
X
X
MG
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate, USP) Tablets 
X
X
X
X
 
Zomig (zolmitriptan) Nasal Spray 
X
X
X
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arixtra (fondaparinux sodium) Injection   
X
X
X
 
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets  
X
X
X
PPI
Avandia (rosiglitazone maleate) Tablets  
X
X
 
MG
Clolar (clofarabine) Injection for Intravenous Use  
X
X
X
 
Cordarone (amiodarone HCl) Tablets  
X
X
X
 
Exjade (deferasirox) Tablets for Oral Suspension  
X
X
 
PPI
Ortho Evra (norelgestromin / ethinyl estradiol transdermal system)  
X
   

Pamidronate Disodium (pamidronate disodium injection) Solution for Intravenous Infusion

Pamidronate Disodium (pamidronate disodium injection) Powder, Lyophilized, for Solution for Intravenous Infusion

  
X
X
X
 
Precedex (dexmedetomidine hydrochloride) Injection for Intravenous Infusion [following dilution]  
X
X
X
 
Sutent (sunitinib malate) Capsules  
X
X
X
 
Treanda (bendamustine hydrochloride) for Injection, for Intravenous Infusion  
X
X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Atrovent (ipratropium bromide) Nasal Spray, Metered     
X
  
Cefazolin for Injection USP and Dextrose Injection USP   
X
  
Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution)   
X
  
Diabinese (chlorpropamide) Tablets, USP   
X
  
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules    
X
  
Fosrenol (lanthanum carbonate) Chewable Tablets    
X
  
Glucotrol (glipizide) Tablets   
X
  
Glucotrol XL (glipizide) Extended Release Tablets   
X
  
Glynase PresTab (micronized glyburide tablets)   
X
  
Hylenex recombinant (hyaluronidase human injection)    
X
  
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use
Kaletra (lopinavir and ritonavir) Solution for Oral Use
   
X
  
Micronase (glyburide tablets, USP)   
X
  
Norvir (ritonavir) Capsules and Solution   
X
  
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension    
X
  
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets    
X
  
Prevacid (lansoprazole) Delayed-Release Capsules
Prevacid (lansoprazole) For Delayed-Release Oral Suspension
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
   
X
  
Riomet (metformin hydrochloride oral solution)   
X
  
Skelaxin (metaxalone) Tablets   
X
  
Tenoretic (atenolol and chlorthalidone) Tablets    
X
  
Theophylline in 5% Dextrose Injections USP    
X
  
Theophylline in 5% Dextrose Injection (theophylline injection, solution) USP, in Flexible Plastic Container   
X
  
Theophylline in Dextrose (theophylline anhydrous injection, solution) USP, in VIAFLEX Plus Container   
X
  
Tobi (tobramycin inhalation solution, USP) Nebulizer Solution - For Inhalation Use Only   
X
  
Trusopt (dorzolamide hydrochloride ophthalmic solution)     
X
  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Isentress (raltegravir) Tablets    
X
PPI
Janumet (sitagliptin and metformin hydrochloride) Tablets    
X
 
Januvia (sitagliptin) Tablets    
X
 
Lasix (furosemide) Tablets    
X
 
Lexapro (escitalopram oxalate) Tablets and Oral Solution    
X
 
Myambutol (ethambutol hydrochloride) Tablets    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets     
MG
Requip XL (ropinirole extended-release tablets)     
PPI