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U.S. Department of Health and Human Services

Safety

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March 2011

Safety Label 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
Fareston (toremifene citrate) tablets 
X
  
Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system
 
X     
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Rotarix (Rotavirus Vaccine, Live, Oral) Oral Suspension X    
Strattera (atomoxetine hydrochloride) capsules X   MG 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accuretic (quinapril HCL/hydrochlorothiazide) tablets  X   
Advil Cold & Sinus Liqui-Gels (ibuprofen 200 mg and pseudoephedrine HCl 30 mg) capsules (OTC)   X   
Atacand HCT (candesartan cilexitil/hydrochlorothiazide) tablets   X   
Azasite (azithromycin) ophthalmic solution  XXX 
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) tablets   X  

Dyazide (hydrochlorothiazide/triamterene) capsules

  X   
Etopophos (etoposide phosphate) powder for injection  X   
Inderal (propranolol HCL) tablets
Inderal LA (propranolol hydrochloride) long acting capsules
  X   
Inderide (propranolol hydrochloride/hydrochlorothiazide) tablets  X   
Integrilin (eptifibatide) injection  X X 
Letairis (ambrisentan) tablets  X X 
Lioresal (baclofen) intrathecal  XX  

Lopressor (metoprolol tartrate) tablets

Lopressor HCT (metoprolol tartrate/hydrochlorothiazide) tablets 

  X   
Lotensin HCT (benazapril hydrochloride/hydorchlorothiazide) tablets   X   
Maxzide (triamterene/hydrochlorothiazide) and Maxzide-25 tablets  X   
Microzide (hydrochlorothiazide) capsules  X   
PhosLo (calcium acetate) 667 mg gelcaps  XX 
Sectral (acebutolol hydrochloride) tablets  X   
Talacen (pentazocine hydrochloride and acetaminophen) tablets  XXX 
Tekamlo (aliskiren/amlodipine) tablets  XXX 
Topamax (topiramate) tablets and sprinkle capsules  XXX 
Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide) tablets
 
  XXX 
Vaseretic (enalapril maleate/hydrochlorothiazide) tablets  X   
Yaz (drospirenone/ethinyl estradiol) tablets   X  
Zestoretic (lisinopril/hydrochlorothiazide) tablets  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Bicnu (carmustine) for injection    X 
Humulin R (insulin human [rDNA origin] injection), U-500    X  
Kerledex (betaxolol hydrochloride and chlorthalidone)    X  
Multaq (dronedarone hydrochloride) tablets    X  
PAH (aminohippurate sodium injection) vials    X  
Paxil (paroxetine HCl) tablets, oral solution
Paxil CR (controlled-release) tablets
 
   X  
Pradaxa (dabigatran etexilate mesylate) capsules   X  
Trileptal (oxcarbazepine) tablets and suspension    X 
Zostavax (zoster vaccine live) suspension for subcutaneous injection   X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AccuNeb (albuterol sulfate) inhalation solution    X 
Aredia (pamidronate disodium) for injection    X 
Aromasin (exemestane) tablets    X 
Doryx (doxycycline hyclate) delayed-release tablets    X 
Flolan (epoprostenol sodium) injection    X 
Lexapro (escitalopram oxalate) tablets and oral solution    X 
Lupron (leuprolide acetate) injection    X 
Monodox (doxycycline monohydrate) capsules    X 
Neurontin (gabapentin) capsules, tablets, and oral solution    
X
 
Nexavar (sorafenib tosylate) tablets    X 
Precose (acarbose) tablets    X 
Propecia (finasteride) 1 mg tablet     X 
Reclast (zoledronic acid) injection     X 
Veletri (epoprostenol sodium) injection    X 
Xyzal (levocetirizine dihydrochloride) oral solution and tablets
 
    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AndroGel (testosterone) 1% gel      PCI/MG 
Pristiq (desvenlafaxine) extended-release tablets      MG