Drug Safety Labeling Changes - January  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
Aliskiren	-	-	-	-
Aliskiren and Amlodipine	-	-
Aliskiren and hydrochlorothiazide	-	-
Aliskiren and valsartan	-	-
Aliskiren, Amlodipine and Hydrochlorothiazide	-	-
Amlodipine , Hydrochlorothiazide and Olmesartan	-			-
Amlodipine and Benazepril	-			-
Amlodipine and Olmesartan	-			-
Amlodipine and Valsartan	-			-
Amlodipine, Valsartan and Hydrochlorothiazide	-			-
Azacitidine	-	-	-
Azelastine	-	-	-
Benazepril	-			-
Benazepril HCl and Hydrochlorothiazide	-			-
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets	-			-
Bromocriptine	-	-		-
Bupivacaine hydrochloride and epinephrine bitartrate injection	-	-	-	-
Bupropion	-	-		-
Ceftriaxone for Injection and Dextrose Injection in Duplex Container			-
Cetuximab	-			-
Clindamycin
Clozapine	-
Colesevelam Hcl	-	-	-
Dabigatran	-			-
Darifenacin	-	-	-
Dronedarone	-	-		-
Eprosartan	-			-
Eprosartan Mesylate Hydrochlorothiazide	-			-
Esomeprazole	-
Ezetimibe	-	-		-
Ezetimibe and simvastatin	-
Fenofibric Acid	-	-	-
Formoterol	-
Gabapentin	-			-
Hydroxyurea	-	-		-
Iloperidone	-			-
Irbesartan	-			-
Irbesartan and Hydrochlorothiazide	-			-
Leuprolide	-	-	-
Marcaine and Marcaine with Epinephrine Injection	-	-		-
Marcaine Spinal Injection	-	-	-	-
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets	-			-
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, and 80/12.5 mg, and 80/25 mg Tablets			-
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets			-
Moexipril HCl Hydrochlorothiazide Tablets	-	-	-	-
Morphine	-
Nafarelin	-	-	-
Naproxen and Esomeprazole Magnesium	-
Orlistat				-
Quinapril	-			-
Quinapril HC- Hydrochlorothiazide Tablets	-			-
Ramipril	-			-
Solifenacin	-	-	-
Telmisartan	-			-
Telmisartan and Amlodipine		-	-
Trandolapril	-			-
Trandolapril- Verapamil	-			-
Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets	-		-	-
Valsartan	-			-
Valsartan and Hydrochlorothiazide	-			-
Varenicline	-
Zonisamide	-	-	-

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