Safety

July 2016

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

PI=PATIENT INFORMATION

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

BW

C

W

P

AR

PPI/MG
Avelox (moxifloxacin hydrochloride)X XXXPCI, MG
Cipro (ciprofloxacin hydrochloride) Tablets, Solution, Oral Suspension
Cipro XR (ciprofloxacin extended release) Tablets
  
X
 XXXPCI, MG
Factive (gemifloxacin mesylate)  
X
 XXXPCI, MG
Levaquin (levofloxacin) 
X
  X XXPCI, MG
Moxifloxacin InjectionX XXXPCI, MG
Noroxin (norfloxacin)X XXXPCI, MG
Synjardy (empagliflozin and metformin hydrochloride) XXXX PCI, MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Evotaz (atazanavir/cobicistat)  XXX PCI, PI
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)  XXXXPCI
Isoniazid Tablets X  X 
Lamprene (clofazimine)  XXXXPCI
Mirvaso (brimonidine) XXXXMG
Prismasol and Phoxillum Renal Replacement Solution XXXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Acetadote (acetylcysteine) Injection   XXX 
Aromasin (exemestane)   XX PCI
Caprelsa (vandetanib)   XX PCI
Eliquis (apixaban)   XX  PCI, MG
Epivir (lamivudine) Tablets and Oral Solution   XX PCI
Faslodex (fulvestrant)   XXXMG
Glyxambi (empagliflozin and linagliptin)   XXXPCI, MG
Humulin R U-500 (insulin human injection)   XX PCI, PI
Ilaris (canakinumab)  XX PCI
Jardiance (empagliflozin)   XX PCI, PI
Kepivance (palifermin) Injection   XXX 
Namzaric (memantine and donepezil hydrochlorides) Extended-release     
Thallous Chloride T1201 Injection   XXX 
Yondelis (trabectedin)   X XX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Alinia (nitazoxanide)   XXPCI
Asmanex HFA (mometasone furoate)   X  
Clinolipid (lipid injectable emulsion)   XXPCI
Dexilant (dexlansoprazole delayed-release capsules)     XXMG
Dulera (formoterol fumarate, mometasone furoate)    X PCI, MG
Dysport (abobotulinumtoxinA)   XXMG
Effient (prasugrel)    XX 
Flovent Diskus (fluticasone propionate inhalation powder)    XX 
Flovent HFA (fluticasone propionate)   X  
Kadcyla (ado-trastuzumab emtansine)   X  
Mirapex (pramipexole)    X  
Mirapex ER (pramipexole) extended-release    XXPCI, PI
Plegridy (peginterferon beta-1a)    X PCI, MG
Pravachol (pravastatin sodium)    XXPCI
Tarka (trandolapril/verapamil hydrochloride ER tablets)    X  
Xolair (omalizumab) Lyophilized Powder    XXMG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Brilinta (ticagrelor)     
X
 
Cubicin (daptomycin for injection)     
X
 
Decadron (dexamethasone)     
X
 
Docetaxel Injection     
X
PI
Durezol (difluprednate)     X 
Merrem I.V. (meropenem for injection)     X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Fluoroplex (fluorouracil)      PI
Habitrol Patch (nicotine transdermal system)      PI
Repatha (evolocumab)     PCI, PI
 
 
   

 

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