Safety

December 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
Aciphex (rabeprazole sodium) Delayed-Release Tablets  XXX  
Dexilant (dexlansoprazole) delayed-release capsules XXX  
Lastacaft (alcaftadine ophthalmic solution)  XXXXPCI
Nexium (esomeprazole magnesium) delayed-release capsules, for oral use XXX  
Nexium I.V. (esomeprazole sodium) for injection XXX  
Onfi (clobazam) tablets, for oral use
Onfi (clobazam) oral suspension
 X XX 

Prevacid (lansoprazole) delayed release capsules

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

 XXX  
Protonix (pantoprazole sodium) delayed-release tablets XXX  
Protonix IV (pantoprazole sodium) XXX  
Somutaline depot (lanreotide) Injection  XXXX 
Tecfidera (dimethyl fumarate) delayed-release capsules, for oral use XXX PCI
Vibativ (telavancin) for injection, for intravenous use  XXX  
Wellbutrin XL (bupropion hydrochloride extended-release) tablets for oral use   XXX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Abilify (aripiprazole) Tablets
Abilify DISCMELT (aripiprazole) Orally Disintegrating Tablets
Abilify (aripiprazole) Oral Solution
Abilify (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY
 
  XX  
Abilify MAINTENA (aripiprazole) for extended-release injectable suspension, for intramuscular use  XX  
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)  XX  
Brisdelle (paroxetine) capsules, for oral use   XXXPCI, MG
Cyramza (ramucirumab) injection, for intravenous use  XX  
Dextrose in Plastic Container  XXX 
Extavia (interferon beta-1b) for injection, for subcutaneous use  XXXPCI, MG 
Gazyva (obinutuzumab) Injection, for Intravenous Infusion  XX  
Geodon (ziprasidone HCl) capsules   XXXPCI 

Idamycin (idarubicin hydrochloride for injection, USP) 

Idamycin PFS

  X   
Jakafi (ruxolitinib) tablets, for oral use   XXXPCI
Kalydeco (ivacaftor) Tablets  XX PCI 
Micardis (telmisartan) Tablets    XX  
Omeclamox-Pak (omeprazole/clarithromycin/amoxicillin)  XX  
Orencia (abatacept)   XX  
Potassium chloride in 5 Percent Dextrose Injection, USP in Plastic Container   XXX 
Prilosec (omeprazole) delayed-release capsules
Prilosec (omeprazole magnesium) for delayed-release oral suspension
  XX  
Qnasl (beclomethasone dipropionate) Nasal Aerosol   XX  
Sarafem (fluoxetine hydrochloride tablets) for oral use   XX PCI, MG
Simponi (golimumab) injection, for Subcutaneous Use
Simponi Aria (golimumab) Injection, for Intravenous Use
 
  XXX 
Sodium Chloride Injection, USP in VIAFLEX Plastic Container  XXX 
Somatuline Depot (lanreotide) Injection   XX  
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) fixed dose combination tablets  XXXPCI
Subutex (buprenorphine) sublingual tablet  XX  
Suboxone (buprenorphine and naloxone) sublingual tablets for sublingual administration  XX  
Sutent (sunitinib malate) capsules  XX PCI
Symbyax (fluoxetine hydrochloride; olanzapine)  XXX 
Twynsta (telmisartan/amlodipine) Tablets   XX  
Vimovo (naproxen and esomeprazole magnesium) delayed release tablets  XX  
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension  X  
Zubsolv (buprenorphine and naloxone sublingual tablets) for sublingual administration   XX  
Zyprexa (olanzapine) Tablets   
Zyprexa Orally Disintegrating Tablets
Zyprexa Zydis
Zyprexa Relprevv
 
  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Camptosar (irinotecan hydrochloride) Intravenous Injection    X  
Capoten (Captopril Tablets, USP)    X  
Cordarone (amiodarone HCl) Tablets   XX 
Exparel (bupivacaine liposome injectable suspension)    X  
Lamictal (lamotrigine) Tablets
Lamictal (lamotrigine) Chewable Dispersible Tablets
Lamictal ODT (lamotrigine) Orally Disintegrating Tablets
Lamictal XR Extended-Release Tablets
   X  

Lotensin (benazepril hydrochloride) Tablets 

*RAS Dual Blockade

   X  

Lotensin HCT (20033) (benazepril hydrochloride/hydrochlorothiazide USP Combination Tablets) 

*RAS Dual Blockade

   X  

Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules 

*RAS Dual Blockade

   X  

Mavik (trandolapril tablets)

*RAS Dual Blockade

   X  
Merrem I.V. (meropenem for Injection)    XX 
Micardis HCT (telmisartan and hydrochlorothiazide) Tablets    X  
Plasma-Lyte 56 and Dextrose 5 percent in Plastic Container   X  
Taclonex (calcipotriene and betamethasone dipropionate) Ointment    X PCI

Tarka (trandolapril/verapamil hydrochloride ER tablets) 

*RAS Dual Blockade

   X  

Vaseretic (enalapril Maleate-hydrochlorothiazide)

*RAS Dual Blockade

   X  

Vasotec (enalapril) Tablets 

*RAS Dual Blockade

   X  
Zestoretic (lisinopril and hydrochlorothiazide)    X  
Zestril (lisinopril) tablets, for oral use    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Acuvail (ketorolac tromethamine ophthalmic solution)     
X
 
Mozobil (plerixafor injection), Solution for Subcutaneous Use     X 
Primaxin I.V. (Imipenum and cilastatin for injection)      X 
Tivicay (dolutegravir) Tablets for Oral Use     X 
Topamax (topiramate) Tablets
Topamax (topiramate) Sprinkle Capsules
    X 
Vizamyl (flutemetamol F 18 injection) for intravenous use     X 
Xarelto (rivaroxaban) Tablets     X 
 
 
   

 

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