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U.S. Department of Health and Human Services

Safety

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July 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
Arixtra (fondaparinux sodium) Solution for Injection 
X
 XX  
Linzess (linaclotide) capsulesXXXX PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Afinitor (everolimus) tablets for oral administration
 
  XXX 
Afinitor Disperz (everolimus tablets for oral suspension)    XXX 

Anafranil (clomipramine) Capsules

* risk of angle-closure glaucoma

  XXXMG

Aptryxol (desvenlafaxine) extended-release Tablets 

* risk of angle-closure glaucoma

  XXXMG

Aristocort Forte (Triamcinolone Diacetate, USP) Injectable Suspension

* risk of serious neurologic adverse reactions with epidural admnistration

  X   

Aristospan (triamcinolone hexacetonide) Injection Suspension

* risk of serious neurologic adverse reactions with epidural admnistration

  X   

Brintellix (vortioxetine) Tablets 

* risk of angle-closure glaucoma

  XXXMG

Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate) Injection Suspension

* risk of serious neurologic adverse reactions with epidural admnistration

  X   

Celexa (citalopram hydrobromide) Tablets

* risk of angle-closure glaucoma

  XXXMG

Cymbalta (duloxetine hydrochloride) Capsules

* risk of angle-closure glaucoma

  XXXMG

DEPO-MEDROL  (methylprednisolone acetate injectable suspension, USP) 

* risk of serious neurologic adverse reactions with epidural admnistration

  X   

Desvenlafaxine Fumarate Extended-Release Tablets 

* risk of angle-closure glaucoma

  XXXMG

Desyrel (trazodone hydrochloride) Tablets

* risk of angle-closure glaucoma

  XXXMG
Docetaxel Injection   XXXPCI

Effexor XR (venlafaxine hydrochloride) extended-release tablets 

* risk of angle-closure glaucoma

  XXXMG

Fetzima (levomilnacipran) extended-release capsules

* risk of angle-closure glaucoma

  XXXMG
Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray for Intranasal Use   XXX 
Flomax (tamsulosin hydrochloride) Capsules   XXX 

Fluoxetine Tablets

* risk of angle-closure glaucoma

  XXXMG

Forfivo XL (bupropion hydrochloride Extended-Release Tablets 

* risk of angle-closure glaucoma

  XXXMG

Hexadrol (dexamethasone sodium phosphate) Injection

* risk of serious neurologic adverse reactions with epidural admnistration

  X   
Humatrope (somatropin [rDNA origin] for injection)   XX  
Jakafi (ruxolitinib phosphate) Tablets  XX  
Kadcyla (ado-trastuzumab emtansine) for injection, for intravenous Use   XXX 

Kenalog Injection (triamcinolone acetonide injectable suspension) 

* risk of serious neurologic adverse reactions with epidural admnistration

  X   

Khedezla (desvenlafaxine base extended-release) Tablets

* risk of angle-closure glaucoma 

  XXXMG

Lexapro (escitalopram oxalate) Tablets and Oral Solution

* risk of angle-closure glaucoma

  XXXMG

Luvox (fluvoxamine maleate) Tablets

* risk of angle-closure glaucoma

  XXXMG

Luvox CR (fluvoxamine maleate) Extended-Release Capsules

* risk of angle-closure glaucoma

  XXXMG

Norpramin (desipramine hydrochloride tablets USP)

* risk of angle-closure glaucoma

  XXXMG

Oleptro (trazodone hydrochloride) extended-release tablets

* risk of angle-closure glaucoma

  XXXMG

Pamelor (nortriptyline HCl) Solution (Pamelor (nortriptyline HCl) Capsules

* risk of angle-closure glaucoma

  XXXMG

Paxil (paroxetine hydrochloride) tablets, oral suspension and controlled-release tablets

* risk of angle-closure glaucoma

  XXXMG

Pexeva (paroxetine mesylate) Tablets

* risk of angle-closure glaucoma

  XXXMG

Pristiq (desvenlafaxine) Extended-Release Tablets

* risk of angle-closure glaucoma

  XXXMG

Prozac (fluoxetine hydrochloride) Delayed Release Capsules

* risk of angle-closure glaucoma

  XXXMG

Prozac (fluoxetine hydrochloride) Pulvules

* risk of angle-closure glaucoma

  XXXMG

Remeron (mirtazapine) Tablets Remeron SolTab orally disintegrating tablets

* risk of angle-closure glaucoma

  XXXMG

Sinequan (doxepin hydrochloride) Capsules and Oral Concentrate

* risk of angle-closure glaucoma

  XXXMG

Solu-Cortef (hydrocortisone sodium succinate) Injection and Sterile Powder for Injection

* risk of serious neurologic adverse reactions with epidural admnistration

  X   
Solu-Medrol (methylprednisolone sodium succinate) Sterile Powder for Injection

* risk of serious neurologic adverse reactions with epidural admnistration 

  X   

Surmontil (Trimipramine Maleate) Capsules 

* risk of angle-closure glaucoma

  XXXMG

Symbyax (olanzapine and fluoxetine hydrochloride) Capsules

* risk of angle-closure glaucoma

  XXXMG

Tofranil-PM (imipramine pamoate) Capsules

* risk of angle-closure glaucoma

  XXXMG
Trelstar (triptorelin pamoate for injectable suspension) Intramuscular use  XX  

Trileptal (oxcarbazepine) film-coated tablets and oral suspension for oral administration 

  XX  
Vantas (histrelin acetate) subcutaneous implant  XX  

Venlafaxine Hydrochloride Extended-Release Capsules

* risk of angle-closure glaucoma

  XXXMG
Victrelis (boceprevir) Capsules  XX MG

Viibryd (vilazodone hydrochloride) Tablets 

* risk of angle-closure glaucoma

  XXXMG

Vivactil (protriptyline HCL) Tablets 

* risk of angle-closure glaucoma

  XXXMG

Wellbutrin (bupropion hydrochloride) Wellbutrin SR and Wellbutrin XL Sustained-Release Tablets

* risk of angle-closure glaucoma

  XXXMG
Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets  XX  

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate 

* risk of angle-closure glaucoma

  XXXMG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Azor (amlodipine and olmesartan medoxomil) tablets, for oral use    X  
Edarbi (azilsartan medoxomil) Tablets    X  
Edarbyclor (azilsartan medoxomil/chlorthalidone) Tablets    X  
Effexor XR (venlafaxine hydrochloride) extended-release tablets    X  
Excedrin Migraine (acetaminophen and caffeine) Tablets, Caplets and Geltabs    X  
Lupron (leuprolide acetate) Injection    X  
Namenda XR (Memantine Hydrochloride Extended-Release) Capsules    X  
Teveten (eprosartan mesylate)
 
   X  
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adderall XR (dextroamphetamine mixed salts of a single entity amphetamine product) Capsules     
X
 
Biaxin Filmtabs (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension USP)
Biaxin XL Filmtabs (clarithromycin extended release tablets)
    X 
Cardene (nicardipine hydrochloride) Injection    X 
Crestor (rosuvastatin calcium) tablets    X 
Crixivan (indinavir sulfate)      
X
PI
Implanon (etonogestrel implant), For Subdermal Use      X 
Nexplanon (etonogestrel implant), Radiopaque, Subdermal Use Only    X 
Vyvanse (lisdexamfetamine dimesylate) Capsules    X