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U.S. Department of Health and Human Services

Safety

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May 2014

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
Accupril (quinapril) tablets X X  
Accuretic (quinapril HCl/hydrochlorothiazide) tablets X X  
Avandia (rosiglitazone maleate) tablets
Avandaryl (rosiglitazone maleate and glimepiride) tablets
Avandamet (rosiglitazone maleate and metformin hydrochloride) tablets
 X    
Edurant (rilpivirine) tablets  X XX 
Jentadueto (linagliptin and metformin hydrochloride) tablets  XXXXPCI
Soriatane (acitretin) capsules XX X 
Tradjenta (linagliptin) tablets XXXXPCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Apidra (insulin glulisine [rDNA origin]) injection   XX  
Altace (ramipril) capsules  XX  
Aromasin (exemestane) oral tablets   XXX 
Azilect (rasagiline mesylate) tablet  XX  
Bydureon (exenatide extended-release) for injectable suspension   XXMG
Gemzar (gemcitabine) for injection   XXX 
Lunesta (eszopiclone) tablets   XX  
Sustiva (efavirenz) capsules and tablets  XX  
Temodar (temozolomide) for injection
Temodar (temozolomide) capsules
 
  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adempas (riociguat) tablets    X  
Aloxi (palonosetron hydrochloride) injection    X  
Avalide (irbesartan/hydrochlorothiazide)    X  
Avapro (irbesartan)
 
   X  
Cleocin HCl (clindamycin hydrochloride) vaginal cream
Cleocin Phosphate (clindamycin phosphate) vaginal suppositories and vaginal ovules
 
   X  
Colestid (colestipol HCl) granules and tablets    X  
Humira (adalimumab)    X  
Invokana (canagliflozin) tablets    X  
Tivicay (dolutegravir) tablets    X  
Xalkori (crizotinib) capsules    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Dopamine Hydrochloride injection

Dopamine Hydrochloride and 5% Dextrose injection

    X 
Gleevec (imatinib mesylate) tablets     X 
Humira (adalimumab)    X 
Implanon (etonogestrel)  implants      
X
 
Levaquin (levofloxacin) tablets, injection, and oral solution     
X
 
Lumizyme (alglucosidase alfa)    X 
Myozyme (alglucosidase alfa)    X 
Nexplanon (etonogestrel) implants     
X
 
Zytiga (abiraterone acetate) tablets     
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arimidex (anastrozole) tablets     PCI 
Synribo (omacetaxine mepesuccinate) for injection      PCI