Drug Safety Labeling Changes - August 2010

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August 2010

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
Meridia (sibutramine hydrochloride) capsules-ContraindicationsWarningsPrecautions----
Exelon Patch (rivastigmine) transdermal system--WarningsPrecautionsAdverse Reactions---
Flagyl (metronidazole) tablets, capsules, and Flagyl ER tablets--Warnings-Adverse Reactions---
Heparin Sodium in the 5% Dextrose injection and in the 0.9% Sodium Chloride injection--Warnings-----
Risperdal (risperidone) tablets, Risperdal (risperidone) oral solution, and Risperdal M-Tab (risperidone) oral disintegrating tablets--WarningsPrecautionsAdverse Reactions---
Augmentin XR (amoxicillin/clavulanate potassium) extended release tablets---Precautions----
Imitrex (sumatriptan) tablets---Precautions----
Taxol (paclitaxel) for injection---PrecautionsAdverse Reactions---
Zomig (zolmitriptan) tablets and orally disintegrating tablets---Precautions----
Lupron Depot - Ped (leuprolide acetate for depot suspension) Injection, Powder for Suspension----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Risperdal Consta (risperidone) long-acting injection----Adverse Reactions---
Valturna (aliskiren/valsartan) combination tablets----Adverse Reactions---
Xalatan (latanoprost) ophthalmic solution----Adverse Reactions---
Zithromax (azithromycin) tablet, single-dose packet, IV for injection, and oral suspension----Adverse Reactions---
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