Drug Safety Labeling Changes - June 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes June - 2014, 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
Olmesartan Medoxomil-Hydrochlorothiazide Tablets	-	-
Somatropin [rDNA origin] for Injection	-			-
Somatropin [rDNA origin]) for Injection	-	-		-
Alprostadil - for Injection	-	-		-
Amlodipine and Olmesartan Medoxomil - Tablets, for oral use	-	-	-
Caverject Impulse Dual Chamber System (alprostadil for injection)	-	-		-
Clindamycin - Capsules	-
Clindamycin - injection, USP and Clindamycin - injection in 5 percent dextrose	-
Denosumab - Injection for Subcutaneous Use	-			-
Denosumab Injection	-			-
Emtricitabine, Rilpivirine, Tenofovir -Tablets, for Oral Use	-			-
Entacapone - Tablets	-	-		-
Etonogestrel/Ethinyl Estradiol Vaginal Ring	-	-	-
Fosphenytoin - Injection	-	-		-
Gattex (teduglutide [rDNA origin]) for Subcutaneous Injection	-	-	-
Glycerol Phenylbutyrate - Oral Liquid	-	-		-
Hydroxyzine - Capsules and Oral Suspension	-	-	-
Increlex (mecasermin [rDNA origin]) injection	-	-	-
Irbesartan and Hydrochlorothiazide -Tablets	-		-
Itraconazole - Capsules
Itraconazole - Oral Solution
Lamotrigine -Tablets Lamotrigine - Chewable Dispersible Tablets Lamotrigine - Orally Disintegrating Tablets Lamotrigine - Extended-Release Tablets	-	-	-	-
Leuprolide acetate - for Depot Suspension	-			-
Lisinopril - Tablets	-
Norethindrone - Tablets	-	-	-
Obinutuzumab - Injection	-			-
Ocriplasmin - Intravitreal Injection, 2.5 mg/mL	-	-		-
Olmesartan Medoxomil - Tablets, for Oral Use	-	-
Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide - Tablets	-	-
Orlistat - Capsules	-	-	-	-
Oxcarbazepine - Film-Coated Tablets and Oral Suspension	-			-
Pazopanib - Tablets	-	-		-
Pegademase Bovine - Injection	-	-	-
Pramlintide Acetate Injection	-
Somatropin [rDNA origin]) for Injection	-			-
Somatropin [rDNA origin]) for Injection	-			-
Sumatriptan - Injection				-
Sunitinib - capsules, oral	-			-
Testim Testosterone Gel	-		-
Testosterone - Buccal System	-		-
Testosterone - gel	-		-
Testosterone - Gel 1% and 1.62%	-		-
Testosterone - Injection	-		-
Testosterone - Topical Solution	-		-
Testosterone - Transdermal System	-		-
Testosterone Enanthate - Injection	-		-
Testosterone Gel	-		-
Thalidomide - Capsules	-			-
Topotecan - Capsules	-	-		-
Trastuzumab - Intravenous Infusion	-
Ulipristal Acetate - Tablet	-			-
Valproic acid - Capsules Valproic acid - Oral Solution Divalproex Sodium Delayed Release Divalproex sodium coated particles in capsules Valproate - Injection Divalproex sodium Extended Release Tablets	-	-	-