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
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 XXBetapace 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) TabletsXX 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 TabletsActoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride extended-release) fixed-dose combination Tablets
X
*NSAID interaction
X Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Extended Release Tablets X*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 XZestoretic (lisinopril and hydrochlorothiazide) Tablets
*NSAID interaction X*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