Drug Safety Labeling Changes - April 2016

Creator: Madhumathi Palaniappan
Keywords: FDA label changes April - 2016, 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
Romiplostim - for Injection, for Subcutaneous Use	-	-
Abacavir, Dolutegravir, and Lamivudine - Tablets, For Oral Use	-	-
Ado-trastuzumab emtansine - for Injection, for Intravenous Use	-	-	-	-
Afatinib - Tablets, for Oral Use	-			-
Alogliptin- Tablets, for Oral Use	-			-
Amiodarone-Tablets	-
Bupropion - Tablets, For Oral Use	-	-	-
Caspofungin acetate - for Injection, for Intravenous Use	-	-	-
Certolizumab - for Injection, for Subcutaneous Use	-
Chlordiazepoxide and Amitriptyline	-	-		-
Crizotinib -Capsules, for Oral Use	-	-	-
Dexmedetomidine - Injection and Dexmedetomidine in 0.9% Sodium Chloride Injection	-
Dolutegravir - Tablets, For Oral Use	-	-
Doxycycline - for Oral Suspension , Doxycycline Hyclate capsules, USP , Doxycycline calcium oral suspension Syrup , Doxycycline Hyclate Tablets, USP	-			-
Doxycycline - Intravenous	-			-
Gemfibrozil -Tablets, USP				-
Interferon beta-1b -for Injection, for Subcutaneous Use	-			-
Lenvatinib - Capsules, for Oral Use	-			-
Levonorgestrel-releasing intrauterine system	-
Liraglutide - Injection, for Subcutaneous Use	-	-	-
Lisinopril- Tablets, for Oral Use	-	-		-
Ombitasvir, Paritaprevir, and Ritonavir Tablets; Dasabuvir Tablets, Co-packaged for Oral Use	-	-		-
Oxaliplatin - Injection for Intravenous Use	-
Rabeprazole - Delayed-release Tablets, for Oral Use and Delayed-release capsules		-	-	-
Ringer’s Injection, USP in VIAFLEX Plastic Container				-
Saxagliptin - Tablets, for Oral Use	-			-
Tadalafil - Tablets, For Oral Use	-	-
Zoledronic acid - Injection	-	-	-
Zonisamide - Capsules, for Oral Administration	-		-	-