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U.S. Department of Health and Human Services

Safety

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October 2009

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, REMS=RISK EVALUATION AND MITIGATION STRATEGY

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

BW

C

W

P

AR

PPI/MG
Azulfidine (sulfasalazine) and Azulfidine EN  (sulfasalazine delayed release) tablets   X X   X  
Lotrel (amlodipine besylate/benazepril hydrochloride) capsules   X   X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
CellCept (mycophenolate mofetil) capsules, tablets, intravenous injection and oral suspension     X   X MG
Hepsera (adefovir dipivoxil) 10 mg tablets     X X X PPI
Invanz (ertapenem) for injection     X X    
Invega (paliperidone) ER tablets     X X X  
Ixempra kit (ixabepilone) for intravenous infusion     X X    
MultiHance (gadobenate dimeglumine) injection     X      
Myfortic (mycophenolic acid) delayed-release tablets     X   X MG
Neoral (cyclosporine) Modified soft gelatin capsules and oral solution     X   X  
Norpramin (desipramine hydrochloride) tablets     X      
Pulmicort Respules (budesonide) inhalation suspension     X   X PPI
Rapamune (sirolimus) oral solution and tablets     X   X  
Sandimmune (cyclosporine) injection, oral solution, and soft gelatin capsules     X   X  
Viread (tenofovir disoproxil fumarate) tablets     X   X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Albenza (albendazole) 200 mg tablets       X    
Anzemet (dolasetron mesylate) tablet and injection       X    
Flomax (tamsulosin hydrochloride) capsule       X    
Kytril (granisetron hydrochloride) injection, tablets and oral solution       X X  
Miacalcin (calcitonin-salmon) nasal spray       X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lialda (mesalamine) delayed-release tablet         X  
Miacalcin (calcitonin-salmon) injection         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Byetta (exenatide) injection           REMS
Chantix (varenicline) tablets           REMS
OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) tablets           REMS
Visicol (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) tablets           REMS