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FDA Labeling Changes

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		X	X	X	X
Reclast (zoledronic acid) Injection		X	X	X		MG
Saphris (asenapine) Sublingual Tablets		X	X	X	X	PCI
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Actos (pioglitazone hydrochloride) Tablets			X	X
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup and Injection			X	X
Betapace and Betapace AF (sotalol HCl) Tablets			X
BiCNU (carmustine for injection)			X		X
DepoCyt (cytarabine liposome injection)			X
Ditropan (Oxybutynin chloride) Tablets			X	X	X
Dostinex (cabergoline) Tablets			X
Exjade (deferasirox) Tablets for Oral Suspension			X	X
Haldol (haloperidol) Injection and Haldol Decanoate IM Injection			X	X
Hyzaar (losartan/hydrochlorothiazide) and Hyzaar (losartan potassium/HCTZ) Tablets			X	X		PPI
Kerledex (betaxolol hydrochloride/chlorthalidone) Tablets			X	X
Kerlone (betaxolol hydrochloride) Tablets			X	X
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Lamictal Orally Disintegrating Tablets, and Lamictal XR Extended-Release Tablets			X	X
Mobic (meloxicam) Tablets and Oral Suspension			X	X
Multaq (dronedarone hydrochloride) Tablets			X	X
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution			X
Platinol (cisplatin for injection, USP)			X		X
Prinzide (lisinopril/hydrochlorothiazide) Tablets			X		X
Sensipar (cinacalcet) Tablets			X	X	X
Tenoretic (atenolol/chlorthalidone) Tablets			X
Tenormin (atenolol) Tablets			X
Thallous Chloride [Tl-201] Injection			X
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate			X	X
(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				X	X
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

Reviewed by:	Review Date:
Joseph V. Madia, MD	Friday, June 17, 2011

Source: FDA

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