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

Safety

  • Print
  • Share
  • E-mail

October 2013

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
Entereg (alvimopan) CapsulesX XXX 
Lovenox (enoxaparin sodium) injectionX XX  
Modicon (norethindrone/ethinyl estradiol)XXXX  
Ofirmev (acetaminophen) Injection  
X
 XX  
Ortho-Cept (desogestrel/ethinyl estradiol) 
X
 X X X  
Ortho-Cyclen (norgestimate/ethinyl estradiol)XXXX  
Ortho Novum (norethindrone/ethinyl estradiol)XXXX  
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)XXXX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Altace (ramipril) Capsules XXX  
Amerge (naratriptan hydrochloride) tablets XXX  
Climara (estradiol) transdermal system and Climara Pro (estradiol/levonorgestrel) transdermal system  XXX  
Diovan (valsartan) Capsules  XXX  
Eovist (gadoxetate disodium) Injection XXX  
Exelon (rivastigmine tartrate) capsules and oral solution  XXXX 
Gadavist (Gadobutrol) Injection XXX  
Glucovance (Glyburide and Metformin HCl) tablets X X  
Glynase PresTab (micronized glyburide) tablets X X  
Incivek (telaprevir) tablets X X  
Lopid (gemfibrozil) Capsules  XXX  
Lysteda (tranexamic acid) Tablets  XXX  
Magnevist (gadopentetate dimeglumine) Injection and Magnevist Pharmacy Bulk Package Injection  X    
Menostar (estradiol) transdermal system  XXX  
Micronase (glyburide) tablets X X  
Relpax (eletriptan hydrobomide) tablets X  
Revia (naltrexone HCl) tablets XXX 
Savella (milnacipran HCl) Tablets  X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actemra (tocilizumab) injection  XX  

Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets

*tenofovir label update

  XXX 

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets

*tenofovir label update

  XXX 
Exjade (deferasirox) tablets, for oral suspension  XXX 
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules   X   
Gleevec (imatinib mesylate) Tablets  XX  

Juvisync (sitagliptin phosphate and simvastatin) tablets

*Simvastatin Interaction with Lomitapide

  XX  
Lantus (insulin glargine [rDNA origin] injection) solution  XX  
Livalo (pitavastatin) Tablets   XX  

Lupron Depot (leuprolide acetate for depot suspension) and Lupaneta Pack (leuprolide acetate for depot suspension; norethindrone acetate tablets) 

  XX PI 
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)     

Stribild (elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate) fixed dose combination tablets 

*tenofovir label update

   

Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets

*tenofovir label update

  XXX 
Ultracet (tramadol HCl/acetaminophen) Tablets  X   

Viread (tenofovir disoproxil fumarate) tablets and oral powder

*tenofovir label update

  XXX 

Vytorin (ezetimibe/simvastatin) Tablets

*Simvastatin Interaction with Lomitapide

  XX  
Xalkori (crizotinib) capsules   XX  
Zaltrap (ziv-aflibercept) Injection   X  

Zocor (simvastatin) Tablets

*Simvastatin Interaction with Lomitapide

  XX  
Zuplenz (ondansetron) oral soluble film  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accupril (quinapril hydrochloride) Tablets   X  
Accuretic (quinapril hydrochloride/HCTZ) Tablets   X  
Amaryl (glimepiride) tablets    X  
Diabeta (glyburide) tablets    X  
Glucotrol (glipizide) tablets    X  
Glucotrol XL (glipizide) Extended Release tablets    X  
Isentress (raltegravir) film-coated tablets and chewable tablets    X  
Metaglip (glipizide/metformin hydrochloride fixed-dose combination) tablets    X  
Monodox (doxycycline monohydrate) capsules    XX 
Nizoral (ketoconazole) 2% shampoo    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension(albumin-bound))

    
X
 
Kineret (anakinra) for injection    X 
Namenda (memantine hydrochloride) tablets     X 
Nexavar (sorafenib tosylate) tablets    X 
Nucynta (tapentadol) immediate-release tablets    X 
Sabril (vigabatrin) tablet and powder for oral solution    X 
Seroquel (quetiapine fumarate) tablets    X 
Seroquel XR (quetiapine fumarate) Extended-Release tablet    X 
Uvadex (methoxsalen) Sterile Solution    X 
Valium (diazepam) Tablets    X 
Vesicare (solifenacin succinate) tablets     
X
 
Xenical (orlistat) capsules   XXPI