Drug Safety Labeling Changes - July 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes July - 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
Mometasone Furoate and Formoterol Fumarate - Inhalation Aerosol	-
Sulfasalazine - Delayed Release tablets, USP	-
Amlodipine and Olmesartan -Tablets	-		-	-
Anagrelide - Capsules	-		-
Aripiprazole - Tablets, Oral Solution, Orally Disintegrating Tablets, and Injectable Formulation	-	-		-
Asparaginase	-
Bactrim and Bactrim DS Tablets	-
Clozapine - Oral Tablets	-	-	-
Denosumab				-
Depacon (valproate sodium) Injection				-
Depakote ER (Extended Release) Tablets				-
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)				-
Divalproex sodium Delayed Release				-
Doxycycline - Capsules	-	-	-
Ertapenem - Injection, 1 gm	-	-	-
Fluoxetine - Delayed Release Capsules	-			-
Fluoxetine - Tablets
Gadobenate- Dimeglumine - Injection and MultiHance Multipack Gadobenate Dimeglumine Injection	-			-
Guanfacine - Tablets	-	-		-
Ketoconazole - Tablets			-	-
Leuprolide - for Depot Suspension	-
Levetiracetam - Tablets, XR tablets, Oral Solution, Injection	-	-	-
Mesalamine - Controlled-Release Capsules	-			-
Naltrexone - for extended-release injectable suspension	-			-
Nifedipine - Capsules	-	-		-
Nifedipine - Tablets	-	-		-
Olanzapine and Fluoxetine - Capsules	-			-
Olmesartan	-
Olmesartan Medoxomil and Hydrochlorothiazide - Tablets	-
Olmesartan Medoxomil/ Amlodipine/ Hydrochlorothiazide - Tablets	-
Oxaliplatin - Injection	-	-	-
Silodosin - Capsules		-	-
Tapentadol - Immediate Release Oral Tablets
Tenofovir - Oral Powder, 40 mg/gram	-	-	-
Valproic acid - Capsules and Oral Solution				-
Vandetanib	-	-	-
Vemurafenib -Tablets	-
Ziprasidone - Capsules, Injection and Oral Suspension	-			-