Drug Safety Labeling Changes - October  2012

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Key to Label Sections

• C - Contraindications
• W - Warnings
• P - Precautions
• AR - Adverse Reactions

Drug Name	Sections Modified
	C	W	P	AR
Ambrisentan		-	-
Amlodipine and Benazepril
Atorvastatin	-
Azilsartan medoxomil		-		-
Azilsartan Medoxomil and Chlorthalidone		-		-
Bevacizumab	-	-	-	-
Bortezomib	-	-	-
Bosentan	-			-
Caduet (amlodipine/atorvastatin) Tablets	-
Canakinumab	-	-	-	-
Certolizumab	-			-
Clomiphene	-
Clomipramine			-	-
Combigan (brimonidine tartrate/timolol maleate) 0.2%/0.5% ophthalmic solution
Duloxetine				-
Entecavir	-	-		-
Esomeprazole	-			-
Everolimus	-	-	-
Ezetimibe and simvastatin	-
Fenofibric Acid	-
Fluvastatin	-
Imipramine			-	-
Ipilimumab	-	-		-
Irbesartan and Hydrochlorothiazide		-		-
Lovastatin	-
Meclizine	-	-	-	-
Milnacipran Hcl	-	-		-
Mirtazapine			-	-
Naproxen and Esomeprazole Magnesium	-			-
Niacin Extended Release and Lovastatin	-
Nortriptyline			-	-
Omeprazole	-
Oxybutynin Hydrochloride	-			-
Pamidronate	-	-	-
Pantoprazole	-			-
Pemetrexed	-			-
Pitavastatin	-
Pravastatin	-
Rabeprazole	-			-
Rituximab	-	-	-
Rosuvastatin	-
Sclerosol Intrapleural Aerosol (sterile talc) powder	-	-		-
Simvastatin	-	-	-	-
Simvastatin and Sitagliptin	-
Sitagliptin	-	-	-
Sitagliptin-Metformin	-	-	-
Telmisartan		-		-
Telmisartan and Amlodipine	-			-
Tocilizumab Injection	-			-
Topiramate	-			-
Valsartan		-		-
Valsartan and Hydrochlorothiazide		-		-
Vandetanib	-	-	-

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes