• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

August 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, 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, PCI=PATIENT COUNSELLING INFORMATION

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

BW

C

W

P

AR

PPI/MG
Eliquis (apixaban) tablets for oral use 
X
 XX  
Estring (estradiol vaginal ring) 
X
XXX PI
Zohydro ER (hydrocodone bitartrate) extended-release capsules, for oral use, CII 
X
 XXXPCI/MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adenoscan (adenosine) injection, for intravenous use   XXXPCI
Axert (almotriptan malate) Tablets for Oral Use   XXXPCI/PI
Elelyso (taliglucerase alfa) for injection, for intravenous use   XXX 
Inlyta (axitinib) tablets for oral administration   XX PCI
Keppra XR (levetiracetam) extended-release tablets, for oral use   XXX 
Nicorette (nicotine polacrilex) Gum [OTC]  X   
Omnitrope (somatropin [rDNA origin] injection), for SUBCUTANEOUS use   XX  
Radiogardase (Prussian Blue Insoluble) capsules, for oral use   XXXPCI
Requip XL (ropinirole) tablet, extended release for oral use   XXXPCI
Vectibix (panitumumab) Injection for intravenous infusion   XXX 
Zemplar (paricalcitol) capsules   XXX 
Zyban (bupropion hydrochloride) Sustained-Release Tablets, for oral Use   XXXPCI/MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Farxiga (dapagliflozin) tablets, 5 mg and 10 mg    X  
Ifex (ifosfamide) for Injection    X  
Intelence (etravirine) 200 mg, 100 mg, and 25 mg tablets    X  
Juxtapid (lomitapide) capsules, for oral use    X  
Pradaxa (dabigatran etexilate mesylate) capsules for oral use    X  
Sylatron (peginterferon alfa-2b) for injection, for subcutaneous use    X MG
Stavzor (valproic acid) Delayed Release Capsules, for oral use    XX 
Vimpat (lacosamide) Tablet, Film Coated for Oral use, CV
Vimpat  (lacosamide) Injection for Intravenous use, CV
Vimpat (lacosamide) Oral Solution, CV
 
   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avastin (bevacizumab) Solution for intravenous infusion     
X
 
Emend (aprepitant) capsules      
X
 
Emend (fosaprepitant dimeglumine) for Injection     
X
 
Halaven (eribulin mesylate) Injection For intravenous administration     X 
Keppra (levetiracetam) tablets, for oral use
Keppra (levetiracetam) oral solution
  
    X 
Keppra (levetiracetam) injection for intravenous use 
 
    X 
Zostavax (Zoster Vaccine Live)      XPPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actoplus MET (pioglitazone and metformin hydrochloride) tablets for oral use      MG
Zorvolex (diclofenac) capsules     MG
 
 
   

 

 
-