Drug Safety Labeling Changes - November 2012

Creator: Madhumathi Palaniappan
Keywords: FDA label changes November - 2012, 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
Adefovir dipivoxil	-			-
Amlodipine and Valsartan		-		-
Amlodipine, Valsartan and Hydrochlorothiazide		-		-
Boceprevir
Certolizumab	-
Chlorhexidine	-		-	-
Dabigatran	-			-
Desipramine			-	-
Febuxostat	-		-	-
Fluvoxamine			-	-
Golimumab	-	-	-
Ketorolac Trometamol Ophthalmic	-			-
Leflunomide	-	-	-
Lubiprostone	-	-	-	-
Methyl Aminolevulinate Hydrochloride	-	-	-
Misoprostol	-			-
Nalidixic Acid	-	-	-
Omeprazole and Sodium Bicarbonate	-
Ondansetron	-			-
Oxybutynin Hydrochloride	-	-	-
Pazopanib	-			-
Prasugrel	-			-
Ritonavir	-			-
Romiplostim	-	-	-
Sunitinib	-	-	-
Telmisartan and Amlodipine		-		-
Tolvaptan	-
Trazodone			-	-
Zoledronic Acid	-	-	-