Drug Safety Labeling Changes - November 2013

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November 2013

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
Prevpac (Lansoprazole 30 mg delayed-release, Amoxicillin 500 mg capsules and Clarithromycin 500 mg tablets)-ContraindicationsWarnings-Adverse Reactions---
Zestoretic (Lisinopril/Hydrochlorothiazide) Tablets-Contraindications--Adverse Reactions---
Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide) Tablets--WarningsPrecautions----
Aralen (Chloroquine Phosphate) Tablets--Warnings-Adverse Reactions---
Jakafi (Ruxolitinib) Tablets--Warnings-----
Lysodren (Mitotane) Tablets--WarningsPrecautionsAdverse Reactions---
Nexavar (Sorafenib) Tablets--Warnings-----
Noxafil (Posaconazole) Delayed-release tablets and Oral Suspension--Warnings-----
Onfi (Clobazam) Tablets and Oral Suspension--WarningsPrecautions----
Remicade (Infliximab) Lyophilized Concentrate for Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Revlimid (Lenalidomide) Capsules--WarningsPrecautions----
Simponi (Golimumab) Injection--WarningsPrecautionsAdverse Reactions---
Tekamlo (Aliskiren and Amlodipine) Tablets--WarningsPrecautions----
Tekturna (Aliskiren) Tablets--WarningsPrecautions----
Tekturna HCT (Aliskiren and Hydrochlorothiazide) Tablets--WarningsPrecautions----
Actoplus Met XR (Pioglitazone Hydrochloride and Metformin Hydrochloride)---Precautions----
Actos (Pioglitazone) Tablets---Precautions----
Caduet (Atorvastatin/Amlodipine) Tablets ---Precautions----
Duetact (Pioglitazone Hydrochloride) Tablet---Precautions----
Fosamax Plus D (Alendronate Sodium/Cholecalciferol) Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Cubicin (Daptomycin) for Injection----Adverse Reactions---
Furadantin (Nitrofurantoin) Oral Suspension----Adverse Reactions---
Somatuline Depot (Lanreotide) Injection ----Adverse Reactions---
Votrient (Pazopanib Hydrochloride) Tablets----Adverse Reactions---
Xyzal (Levocetirizine Dihydrochloride) Tablets and Oral Solution----Adverse Reactions---
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