Drug Safety Labeling Changes - NOVEMBER 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes NOVEMBER - 2013, Drug Name, Sections Modified, Contraindications, Precautions, Adverse Reactions

Written & Compiled by - Madhumathi Palaniappan

Medically Reviewed by - The Medindia Medical Review Team

Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

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

Drug Name	Sections Modified
Drug Name	C	W	P	AR
Lisinopril -Tablets		-	-
Alendronate /Cholecalciferol - Tablets	-	-
Aliskiren - Tablets	-			-
Aliskiren and Amlodipine - Tablets	-			-
Aliskiren and Hydrochlorothiazide - Tablets	-			-
Aliskiren, Amlodipine and Hydrochlorothiazide - Tablets	-			-
Atorvastatin/Amlodipine -Tablets	-	-		-
Chloroquine - Tablets	-		-
Clobazam - Tablets and Oral Suspension	-			-
Crizotinib - Capsules	-			-
Daptomycin - for Injection	-	-	-
Golimumab - Injection	-
Infliximab - Lyophilized Concentrate for Injection	-			-
Lanreotide - Injection	-	-	-
Lansoprazole - 30 mg Delayed-Release, Amoxicillin - 500 mg Capsules and Clarithromycin - 500 mg Tablets			-
Lenalidomide - Capsules	-			-
Levocetirizine Dihydrochloride - Tablets and Oral Solution	-	-	-
Lisinopril/Hydrochlorothiazide - Tablets		-	-
Mitotane - Tablets	-
Nitrofurantoin - Oral Suspension	-	-	-
Pazopanib - Tablets	-	-	-
Pioglitazone - Tablet	-	-		-
Pioglitazone and Metformin Hydrochloride	-	-		-
Pioglitazone - Tablets	-	-		-
Posaconazole - Delayed-release tablets and Oral Suspension	-		-	-
Ruxolitini - Tablets	-		-	-
Sorafenib - Tablets	-		-	-