Drug Safety Labeling Changes - May 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes May - 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
Eszopiclone - Tablets	-			-
Abiraterone Acetate - Tablets	-	-	-
Acitretin - Capsules			-
Adalimumab	-	-	-
Adalimumab	-	-		-
Anastrozole -Tablets	-	-	-	-
Canagliflozin -Tablets	-	-		-
Clindamycin - Vaginal Cream Clindamycin - Vaginal Suppositories and Vaginal Ovules	-	-		-
Colestipol - Granules and Tablets	-	-		-
Crizotinib - Capsules	-	-		-
Dolutegravir -Tablets	-	-		-
Dopamine - injection Dopamine and 5% Dextrose injection	-	-	-
Efavirenz - Capsules and Tablets	-			-
Etonogestrel - Implants	-	-	-
Etonogestrel - Implants	-	-	-
Exemestane - Oral Tablets	-
Exenatide - Extended-Release for Injectable Suspension	-
Gemcitabine - for Injection	-
Imatinib - Tablets	-	-	-
Insulin Glulisine [rDNA origin]) Injection	-			-
Irbesartan	-	-		-
Irbesartan/ Hydrochlorothiazide	-	-		-
Levofloxacin - Tablets, Injection, and Oral Solution	-	-	-
Linagliptin - Tablets
Linagliptin and Metformin Hydrochloride - Tablets
Lumizyme Alglucosidase Alfa	-	-	-
Myozyme Alglucosidase Alfa	-	-	-
Omacetaxine Mepesuccinate - for Injection	-	-	-	-
Palonosetron - Injection	-	-		-
Quinapril - Tablets		-		-
Quinapril and Hydrochlorothiazide - Tablets		-		-
Ramipril - Capsules	-			-
Rasagiline - Tablet	-	-
Rilpivirine - Tablets		-
Riociguat - Tablets	-	-		-
Rosiglitazone - Tablets Rosiglitazone and Glimepiride - Tablets Rosiglitazone and Metformin Hydrochloride - Tablets		-	-	-
Temozolomide - for Injection Temozolomide - Capsules	-			-