Drug Safety Labeling Changes - OCTOBER 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes OCTOBER - 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
Glyburide - Tablets	-	-		-
Glyburide - Tablets		-		-
Lupron Depot (Leuprolide Acetate for Depot Suspension) and Lupaneta Pack (Leuprolide Acetate for Depot Suspension;Norethindrone Acetate Tablets)	-			-
Vigabatrin - Tablet and Powder for Oral Solution	-	-	-
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension(albumin-bound))	-	-	-
Acetaminophen - Injection	-			-
Alvimopan Capsules	-
Anakinra - for Injection	-	-	-
Climara Estradiol Transdermal System and Climara Pro (estradiol/levonorgestrel) Transdermal System				-
Complera (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate) Tablets	-
Crizotinib - Capsules	-			-
Deferasirox - Tablets, for oral suspension	-
Desogestrel/Ethinyl Estradiol				-
Diazepam -Tablets	-	-	-
Doxycycline - Capsules	-	-
Efavirenz/Emtricitabine/Tenofovir - Tablets	-
Eletriptan Hydrobomide Tablets				-
Enoxaparin - Injection	-			-
Estradiol - Transdermal System				-
Fioricet with Codeine Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules	-		-	-
Gadobutrol - Injection				-
Gadopentetate Dimeglumine Injection and Magnevist Pharmacy Bulk Package Injection		-	-	-
Gadoxetate Disodium Injection				-
Gemfibrozil - Capsules				-
Glimepiride - Tablets	-	-		-
Glipizide - Extended Release tablets	-	-		-
Glipizide - Tablets	-	-		-
Glipizide/Metformin Hydrochloride - fixed-dose combination Tablets	-	-		-
Glyburide -Tablets		-		-
Glyburide and Metformin HCl - Tablets		-		-
Imatinib - Tablets	-			-
Juvisync (Sitagliptin Phosphate and Simvastatin) Tablets	-			-
Ketoconazole - 2% Shampoo	-	-		-
Lantus( Sitagliptin phosphate and Simvastatin )Tablets	-			-
Memantine - Tablets	-	-	-
Methoxsalen Sterile Solution	-	-	-
Milnacipran Hydrochloride - Tablets				-
Naltrexone - tablets
Naratriptan - Tablets				-
Norethindrone/Ethinyl Estradiol				-
Norethindrone/Ethinyl Estradiol				-
Norgestimate/Ethinyl Estradiol				-
Norgestimate/Ethinyl Estradiol				-
NuvaRing (Etonogestrel/Ethinyl Estradiol Vaginal Ring)	-			-
Ondansetron -Oral Soluble Film	-			-
Orlistat - Capsules	-	-
Pitavastatin - Tablets	-			-
Quetiapine - Extended-Release Tablet	-	-	-
Quetiapine - Tablets	-	-	-
Quinapril - Tablets	-	-		-
Quinapril and Hydrochlorothiazide - Tablets	-	-		-
Raltegravir - Film-Coated Tablets and Chewable Tablets	-	-		-
Ramipril - Capsules				-
Rivastigmine - Capsules and Oral Solution
Simvastatin - Tablets	-			-
Solifenacin -Tablets	-	-	-
Sorafenib - Tablets	-	-	-
Stribild (Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Disoproxil Fumarate) fixed dose combination Tablets	-
Tapentadol - Immediate-Release Tablets	-	-	-
Telaprevir - Tablets		-		-
Tocilizumab Injection	-			-
Tranexamic acid -Tablets				-
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets	-
Ultracet (Tramadol HCl/ Acetaminophen) Tablets	-		-	-
Valsartan - Capsules				-
Viread Tenofovir disoproxil fumarate Tablets and Oral Powder	-
Vytorin (Ezetimibe/Simvastatin)Tablets	-			-
Zaltrap (ziv-aflibercept) Injection	-			-