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U.S. Department of Health and Human Services

Safety

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June 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, PCI= PATIENT COUNSELING INFORMATION

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

BW

C

W

P

AR

PPI/MG
Sporanox (itraconazole) Capsules 
X
XXXXX
Sporanox (itraconazole) Oral Solution 
X
XXXXX
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Alsuma (sumatriptan) injection  X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Androderm (testosterone) transdermal system 

*thromboembolic events

  X X 

AndroGel (testosterone) gel 1% and 1.62% 

*thromboembolic events

  X X 
Avalide (irbesartan and hydrochlorothiazide) tablets  XX  

Aveed (testosterone undecanoate) injection 

*thromboembolic events

  X X 

Axiron (testosterone) topical solution

*thromboembolic events

  X X 
Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent dextrose)   XXX 
Cleocin HCL (clindamycin hydrochloride) Capsules   XXX 
Complera (emtricitabine, rilpivirine, tenofovir disoproxilfumarate) tablets, for oral use
 
  XX PCI

Delatestryl (testosterone enanthate) injection

*thromboembolic events

  X X 
Ella (ulipristal acetate) tablet  XX  

Fortesta (testosterone) gel

*thromboembolic events

  X X 
Gazyva (obinutuzumab) Injection  XX  
Herceptin (trastuzumab) Intravenous Infusion  X 
Lupron Depot (leuprolide acetate) for depot suspension    

Nutropin AQ (somatropin [rDNA origin]) for injection 

*neoplasms

  XX  
Prolia (denosumab) Injection  X  

Saizen (somatropin [rDNA origin]) for injection

*neoplasms

  XX  

Serostim (somatropin [rDNA origin] for injection)

*neoplasms

  XX  

Striant (testosterone) buccal system

*thromboembolic events

  X X 
Sutent (sunitinib malate) capsules, oral   XX  
Symlin (pramlintide acetate) injection   

Testim (testosterone) gel

*thromboembolic events

  X X 

Testosterone gel

*thromboembolic events

  X X 
Thalomid (thalidomide) capsules   XX  
Trileptal (oxcarbazepine) film-coated tablets and oral suspension    XX  
Xgeva (denosumab) injection for subcutaneous use  XX  
Zestril (lisinopril) tablets  X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Benicar (olmesartan medoxomil) tablets, for oral use

*Increased Risk of CV Death and *Lithium Interaction

   X 

Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) tablets

*Increased Risk of CV Death and *Lithium Interaction

   X 

Caverject (alprostadil for injection)

   X  

Caverject Impulse Dual Chamber System (alprostadil for injection)  

   X  
Cerebyx (Fosphenytoin Sodium Injection)    X  
Comtan (entacapone) Tablets    X  
Hycamtin (topotecan) capsules    X  
Jetrea (ocriplasmin) Intravitreal Injection, 2.5 mg/mL   X  
Ravicti (glycerol phenylbutyrate) Oral Liquid    X  

Tev-Tropin (somatropin [rDNA origin]) for injection 

*neoplasms

   X  

Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets

*Increased Risk of CV Death and *Lithium Interaction

   X 

Votrient (pazopanib) tablets

     
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adagen (pegademase bovine) Injection     
X
 

Azor (amlodipine and olmesartan medoxomil) tablets, for oral use

*Olmesartan medoxomil: information on “ROADMAP” study

    X 
Depakene (valproic acid) Capsules
Depakene (valproic acid) Oral Solution
Depakote (divalproex sodium) Delayed Release
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)
Depacon (valproate sodium) Injection
Depakote ER (divalproex sodium) Extended Release Tablets
     X 
Gattex (teduglutide [rDNA origin]) for subcutaneous injection    X 
Increlex (mecasermin [rDNA origin]) injection    X 
Micronor (norethindrone) Tablets     
X
 
NuvaRing (etonogestrel/ethinyl estradiol) vaginal ring     
X
 
Vistaril (hydroxyzine pamoate) capsules and oral suspension      
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Alli (orlistat) capsules      Patient Info
Lamictal (lamotrigine) tablets
Lamictal (lamotrigine) chewable dispersible tablets
Lamictal ODT (lamotrigine) orally disintegrating tablets
Lamictal XR (lamotrigine) extended-release tablets
 
     MG