Drug Safety Labeling Changes - DECEMBER 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes DECEMBER - 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
Adderall XR (mixed amphetamine salts) Capsules	-	-	-
Alprostadil - for Injection	-	-	-
Belimumab	-			-
Bevacizumab	-
Carboprost - Sterile Solution Injection		-	-
Clopidogrel - Tablets	-
Dabigatran - Capsules	-	-	-
Dabrafenib - Capsules	-	-	-
Desvenlafaxine -Extended-Release Tablets	-	-	-
Dexmethylphenidate Tablets and Focalin XR Dexmethylphenidate Hydrochloride Extended-Release Tablets	-
Dextroamphetamine - Spansule Sustained Release Capsules	-	-	-
Docetaxel - Injection Concentrate	-
Dofetilide - Capsules		-	-	-
Florbetapir F 18 Injection	-	-	-
Ipilimumab	-			-
Lamotrigine - Tablets, Chewable Dispersible Tablets Lamotrigine - Orally Disintegrating Tablets Lamotrigine - Extended-Release Tablets	-	-	-
Lisdexamfetamine - Capsules	-	-	-
Mesalamine - Controlled-Release Capsules	-	-	-
Mesalamine - Delayed-Release Tablets	-	-	-
Mesalamine - Rectal Suppository	-			-
Methamphetamine -Tablets	-	-	-
Methylphenidate - Extended-Release Capsules	-
MethylPhenidate - Extended-Release Oral Suspension	-
Methylphenidate - Extended-Release Tablets	-
Methylphenidate - Oral Solution and Chewable Tablets	-
Methylphenidate - Tablets Methylphenidate - Sustained-Release Tablets Methylphenidate - Extended-Release Capsules	-
Methylphenidate - Transdermal System	-
Montelukast - Tablets, Chewable Tablets, and Oral Granules	-	-	-
Natalizumab - Injection	-			-
Ondansetron - Tablets, Oral Solution, Injection Ondansetron - Orally Disintegrating Tablets	-	-	-
Pantoprazole - for Injection	-	-	-
Pantoprazole -for Delayed-Release Suspension, Delayed-Release Oral Tablets	-	-	-
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution	-	-	-
Pegvisomant - Injection	-	-	-
Ponatinib - Tablets	-			-
Ranolazine - Extended-Release Tablets	-
Strontium-89 Chloride Injection	-	-	-
Ticagrelor -Tablets	-	-	-
Vilazodone Hydrochloride - Tablets	-	-	-