Medication Guide App

Drug Safety Labeling Changes - November 2011

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November 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
Dilantin (phenytoin) Oral Suspension-ContraindicationsWarningsPrecautionsAdverse Reactions---
Amturnide (aliskiren/amlodipine/hydrochlorothiazide) Tablets--WarningsPrecautions----
Isentress (raltegravir potassium) Tablets--WarningsPrecautionsAdverse Reactions---
Lioresal Intrathecal (baclofen injection)--WarningsPrecautions----
Methotrexate Sodium for Injection--Warnings-----
Twynsta (telmisartan/amlodipine)--WarningsPrecautions----
VFEND (voriconazole) Tablets, I.V. for Infusion and Oral Suspension--WarningsPrecautionsAdverse Reactions---
Vimovo (naproxen/esomeprazole magnesium) Tablets--WarningsPrecautionsAdverse Reactions---
Ziagen (abacavir sulfate) Tablets and Oral Solution--WarningsPrecautions----
Zyflo CR (zileuton) Extended Release Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Agrylin (anagrelide hydrochloride) Capsule---Precautions----
Amoxil (amoxicillin) Chewable Tablets, Tablets and Oral Suspension---Precautions----
Cordarone (amiodarone HCl) Tablets---Precautions----
Cozaar (losartan) Tablets---Precautions-Patient Package Insert--
Hyzaar (losartan/hydrochlorothiazide) Tablets---Precautions-Patient Package Insert--
Prinzide (lisinopril/hydrochlorothiazide) Tablets---Precautions-Patient Package Insert--
Protopic (tacrolimus) Ointment---PrecautionsAdverse Reactions---
Treximet (sumatriptan/naproxen) Tablets---Precautions----
Verelan PM (verapamil hydrochloride) Extended-Release CapsulesVerelan (verapamil hydrochloride) Sustained-Release Capsules---Precautions----
Lamisil (terbinafine hydrochloride) Tablets and Oral Granules----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Velcade (bortezomib) for Injection----Adverse Reactions---
Viramune (nevirapine) Tablets, Oral Suspension and Virammune XR Extended-Release Tablets----Adverse Reactions---
AndroGel (testosterone gel)--------
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, and Lamictal XR (lamotrigine) Extended-Release Tablets--------
Testim (testosterone gel)--------
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