Drug Safety Labeling Changes - August 2011

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August 2011

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Accolate (zafirlukast) tablets-Contraindications---Patient Package Insert--
Celexa (citalopram hydrobromide) Tablets and  Oral Solution-ContraindicationsWarningsPrecautionsAdverse Reactions---
Reclast (zoledronic acid) Injection-ContraindicationsWarningsPrecautions----
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup and Injection--WarningsPrecautions----
Betapace and Betapace AF (sotalol HCl) Tablets--Warnings-----
BiCNU (carmustine for injection)--Warnings-Adverse Reactions---
DepoCyt (cytarabine liposome injection)--Warnings-----
Dostinex (cabergoline) Tablets--Warnings-----
Exjade (deferasirox) Tablets for Oral Suspension--WarningsPrecautions----
Haldol (haloperidol) Injection and Haldol Decanoate IM Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Kerledex (betaxolol hydrochloride/chlorthalidone) Tablets--WarningsPrecautions----
Kerlone (betaxolol hydrochloride) Tablets--WarningsPrecautions----
Mobic (meloxicam) Tablets and Oral Suspension--WarningsPrecautions----
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution--Warnings-----
Platinol (cisplatin for injection, USP)--Warnings-Adverse Reactions---
Sensipar (cinacalcet) Tablets--WarningsPrecautionsAdverse Reactions---
Tenoretic (atenolol/chlorthalidone) Tablets--Warnings-----
Tenormin (atenolol) Tablets--Warnings-----
Thallous Chloride [Tl-201] Injection--Warnings-----
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Aceon (perindopril erbumine) Tablets---Precautions----
Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Extended Release Tablets---Precautions----
Duetact (pioglitazone hydrochloride and glimepiride) fixed-dose combination Tablets---Precautions----
Starlix (nateglinide) tablets---Precautions----
Tykerb (lapatinib) Tablets---Precautions----
Uniretic (moexipril hydrochloride/hydrochlorothiazide) Tablets---Precautions----
Univasc (moexipril hydrochloride) Tablets---Precautions----
Zestril (lisinopril) Tablets---Precautions----
Zyban (bupropion hydrochloride) Sustained-Release Tablets ---Precautions----
Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Lyrica (pregabalin) Capsules and Oral Solution----Adverse Reactions---
Xanax (alprazolam) and Xanax XR----Adverse Reactions---
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