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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/MGAccolate (zafirlukast) tablets X   PPICelexa (citalopram hydrobromide) Tablets and  Oral Solution  XXXX Reclast (zoledronic acid) Injection  XXX MGSaphris (asenapine)  Sublingual Tablets XXX XPCI(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MGActos (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 PPIKerledex (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/MGAceon (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/MGDulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol    
X
 Lyrica (pregabalin) Capsules and Oral Solution    
X
 Xanax (alprazolam) and Xanax XR    X 
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