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U.S. Department of Health and Human Services

Safety

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September 2010

SAFETY LABEL 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
Arava (leflunomide) tabletsX    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Zofran (ondansetron hydrochloride) tablets, oral solution, orally disintegrating tablet, and injection X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Aciphex (rabeprazole sodium) delayed-release tablets

*Proton Pump Inhibitor change

  X X  
Alli (orlistat) capsules  X   
Altabax (retapamulin) ointment  X X  
Apokyn (apomorphine hydrochloride) injection  X X  
Casodex (bicalutamide) tablet  X X  

Combunox (Oxycodone HCl/ibuprofen) tablets

  X X  
Desferal (deferoxamine mesylate) injection  X  

Dexilant (dexlansoprazole) delayed release capsules

*Proton Pump Inhibitor change

  X  

Faslodex (fulvestrant) solution for injection

  X  
Minocin (minocycline hydrochloride) pellet-filled capsules, intravenous, and oral suspension  X  

Nexium I.V. (esomeprazole sodium) for injection

*Proton Pump Inhibitor change

  X X  

Nexium (esomeprazole magnesium) delayed-release capsules and delayed release oral suspension

*Proton Pump Inhibitor change

  X X  
Noxafil (posaconazole) oral suspension  XXXPPI

Prevacid (lansoprazole) delayed-release capsules and orally disintegrating tablets

*Proton Pump Inhibitor change

  X  

Prilosec (omeprazole magnesium) delayed release capsules and oral suspension

*Proton Pump Inhibitor change

   XX  

Protonix (pantoprazole sodium) for injection, delayed-release tablets, and oral suspension

*Proton Pump Inhibitor change

  X  

Rotarix (rotavirus vaccine, live, oral) oral suspension

   XX  

Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules

Zegerid with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) chewable tablets and tablets

*Proton Pump Inhibitor change

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

BW

C

W

P

AR

PPI/MG
Cutivate (fluticasone propionate) cream   X 
Cutivate (fluticasone propionate) lotion   X 
Duetact (pioglitazone HCl plus glimepiride) fixed-dose combination tablets   X  
Fazaclo (clozapine) orally disintegrating tablets   XX 
Lopid (gemfibrozil) tablets   X  
Oraqix (lidocaine and prilocaine periodontal) gel   X  
Ranexa (ranolazine) extended-release tablets   X  
Welchol (colsevelam) tablets and oral suspension   X  
Zyban (bupropion hydrochloride) sustained-release tablets   X  MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Janumet (sitagliptin and metformin HCl) fixed-dose combination tablets    
X
 
Januvia (sitagliptin) tablets    
X
 
Platinol and Platinol-AQ (cisplatin) for injection    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Asmanex Twisthaler (mometasone furoate) inhalation powder     PPI 
Klonopin (clonazepam) tablets and orally disintegrating tablets     MG 
Pristiq (desvenlafaxine succinate) extended-release tablets     MG 
Zarontin (ethosuxide) capsules     MG