Drug Safety Labeling Changes - APRIL 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes APRIL - 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
Histrelin Acetate - Subcutaneous Implant	-	-	-
(Liraglutide [rDNA origin]) Injection	-			-
Adapalene - lotion	-	-	-
Alendronate - Effervescent Tablets	-	-
Alendronate - Tablets and Oral Solution	-	-
Alendronate / Cholecalciferol - Tablets	-	-
Artemether/Lumefantrine	-			-
Belatacept - Intravenous Injection	-			-
Benztropine - Injection	-	-		-
Candesartan - Tablets
Candesartan Cilexetil Hydrochlorothiazide Tablets
Cyclobenzaprine -Tablets	-
Cyclobenzaprine Hydrochloride Extended Release Capsules	-			-
Dabigatran - Capsules	-
Doripenem - for Injection	-	-	-
Dutasteride and Tamsulosin - Capsules
Dutasteride Gelatin Capsules	-	-	-
Efavirenz,Emtricitabine,Tenofovir, Disoproxil Fumarate	-			-
Emtricitabine - Capsulests and Oral Solution	-			-
Etidronate - Tablets	-	-
Famicyclovir -Tablets	-	-	-
Fidaxomicin - Tablets				-
Golimumab - Injection	-			-
Histrelin Acetate - Subcutaneous Implant	-
Ibandronate - Injection
Ibandronate - Tablets	-	-
Incobotulinumtoxin A for Injection	-	-	-
Interferon Beta 1-a Injection	-	-		-
Lacosamide - Tablets, Injection and Oral Solution	-	-	-
Laronidase - solution for intravenous infusion	-	-	-
Lomitapide - Capsules	-			-
Pancrelipase - Delayed - Release Capsules	-	-	-
Quetiapine -Tablets	-			-
Quetiapine- Extended Release Tablets	-			-
Quinine - Capsules	-			-
Risedronate - Tablets	-	-
Risedronate Sodium Delayed Release Tablets	-	-
Risedronate with Calcium Carbonate Tablets	-	-
Telaprevir - Film Coated Tablets	-			-
Tenefovir - Tablets and Oral Powder	-			-
Tocilizumab Injection	-			-
Tolvapatan - Tablets	-
Treprostinil - Inhalation Solution	-	-	-
Ustekinumab - Injection	-	-	-
Zaleplon -Capsules	-	-	-
Zolpidem - Sublingual Tablets	-			-
Zolpidem - Tablets
Zolpidem- Extended Release Tablets