Drug Safety Labeling Changes - December 2012

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December 2012

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
Celexa (Citalopram Hydrobromide) Tablets and Oral Solution-ContraindicationsWarnings-----
Effexor (Venlafaxine Hydrochloride) Tablets-ContraindicationsWarnings-----
Effexor XR (Venlafaxine Hydrochloride) Extended-release Capsules-ContraindicationsWarnings-----
Lexapro ( Escitalopram Oxalate) Tablets and Oral Solution-ContraindicationsWarningsPrecautions----
Omontys (Peginesatide) Injection-ContraindicationsWarningsPrecautions----
Paxil (Paroxetine Hydrochloride) Tablets and Oral Suspension-ContraindicationsWarningsPrecautions----
Pradaxa (Dabigatran Etexilate)-ContraindicationsWarningsPrecautions----
Pristiq (Desvenlafaxine) Extended-Release Tablet-ContraindicationsWarningsPrecautions----
Surmontil (Trimipramine Maleate) Capsules-ContraindicationsWarningsPrecautions----
Venlafaxine Extended Release Tablets-ContraindicationsWarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Viibryd (Vilazodone HCL) Tablets-ContraindicationsWarningsPrecautions----
Altabax (Retapamulin) Ointment--WarningsPrecautionsAdverse Reactions---
Antara (Fenofibric Acid) Capsules--WarningsPrecautionsAdverse Reactions---
Fibricor (Fenofibric Acid) Tablets--WarningsPrecautionsAdverse Reactions---
Horizant (Gabapentin Enacarbil) Extended-Release Tablets--WarningsPrecautions----
Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide Tablets--WarningsPrecautions----
Sabril (Vigabatrin) Tablets--WarningsPrecautions----
Tamiflu (Oseltamivir Phosphate) Capsules and Oral Suspension--WarningsPrecautions----
Azulfidine (Sulfasalazine) Tablets, USP---Precautions----
Azulfidine EN-Tabs (Sulfasalazine Delayed Release) Tablets, USP---Precautions----
Drug Name BW C W P AR PPI MG PCI
Benicar (Olmesartan Medoxomil) Tablets---Precautions----
Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) Tablets---Precautions----
Lopressor (Metoprolol Tartrate) Tablets and Injection---Precautions----
Betaseron (Interferon Beta-1b) For Injection----Adverse Reactions---
Enbrel (Etanercept) Injection----Adverse Reactions---
Ionamin (Phentermine Resin) Capsules----Adverse Reactions---
Restasis (Cyclosporine Ophthalmic Emulsion)----Adverse Reactions---
Soliris (Eculizumab) Concentrated Solution For Intravenous Infusion----Adverse Reactions---
Tegretol (Carbamazepine USP) Chewable Tablets, Tablets, Suspension----Adverse Reactions---
Victoza (Liraglutide [rDNA origin]) Injection----Adverse Reactions---
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