• 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 2011

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
Accolate (zafirlukast) tablets X   PPI
Celexa (citalopram hydrobromide) Tablets and  Oral Solution  XXXX 
Reclast (zoledronic acid) Injection  XXX MG
Saphris (asenapine)  Sublingual Tablets XXX XPCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actos (pioglitazone hydrochloride) Tablets  XX  
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup and Injection   XX  

Betapace and Betapace AF (sotalol HCl) Tablets

  X   
BiCNU (carmustine for injection)  X X 
DepoCyt (cytarabine liposome injection)  X   
Ditropan (Oxybutynin chloride) Tablets  XXX 
Dostinex (cabergoline) Tablets  X   
Exjade (deferasirox) Tablets for Oral Suspension  XX  
Haldol (haloperidol) Injection and Haldol Decanoate IM Injection  XX  
Hyzaar (losartan/hydrochlorothiazide) and Hyzaar (losartan potassium/HCTZ) Tablets  XX PPI
Kerledex (betaxolol hydrochloride/chlorthalidone) Tablets  XX  
Kerlone (betaxolol hydrochloride) Tablets  XX  
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Lamictal Orally Disintegrating Tablets, and Lamictal XR Extended-Release Tablets  XX  
Mobic (meloxicam) Tablets and Oral Suspension  XX  
Multaq (dronedarone hydrochloride) Tablets
  XX  
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution  X   
Platinol (cisplatin for injection, USP)  X X 
Prinzide (lisinopril/hydrochlorothiazide) Tablets  X X 
Sensipar (cinacalcet) Tablets  XXX 
Tenoretic (atenolol/chlorthalidone) Tablets  X   
Tenormin (atenolol) Tablets  X   
Thallous Chloride [Tl-201] Injection  X   
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aceon (perindopril erbumine) Tablets   X  
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) fixed-dose combination Tablets
Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride extended-release) fixed-dose combination Tablets
   X  

Altace (ramipril) Tablets

*NSAID interaction

   X  
Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Extended Release Tablets   X  

Avapro (irbesartan) Tablets

*NSAID interaction

   X  
Duetact (pioglitazone hydrochloride and glimepiride) fixed-dose combination Tablets    X  
Starlix (nateglinide) tablets   X  
Tarka (trandolapril/verapamil hydrochloride) Tablets   XX 
Tykerb (lapatinib) Tablets   X  
Uniretic (moexipril hydrochloride/hydrochlorothiazide) Tablets   X  
Univasc (moexipril hydrochloride) Tablets   X  

Zestoretic (lisinopril and hydrochlorothiazide) Tablets

*NSAID interaction
   X  

Zestril (lisinopril) Tablets

*NSAID interaction

   X  
Zyban (bupropion hydrochloride) Sustained-Release Tablets    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol    
X
 
Lyrica (pregabalin) Capsules and Oral Solution    
X
 
Xanax (alprazolam) and Xanax XR    X