Drug Safety Labeling Changes - February 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes February - 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
Acitretin - Capsules	-	-	-	-
Arformoterol Tartrate Inhalation - Solution	-	-	-
Naproxen/Esomeprazole - Delayed-Release Tablets	-	-		-
Omeprazole/Sodium Bicarbonate - Capsules	-	-		-
Sitagliptin and Metformin HCl - Extended-Release Tablets	-	-	-	-
Tolvaptan - Tablets		-	-
Anagrelide - Capsules			-	-
Atomoxetine - Capsules	-	-	-
Azathioprine - Tablets and Injection	-		-	-
Boceprevir - 200 mg Capsules	-
Carbidopa	-
Dexamethasone - Intravitreal Implant	-	-	-
Eltrombopag - Tablets	-
Esomeprazole - Delayed-Release Oral Suspension	-	-		-
Esomeprazole - for Intravenous Injection	-	-		-
Eszopiclone - Film Coated Oral Tablets	-	-	-
Everolimus - Tablets for Oral Administration Everolimus - Tablets for Oral Suspension	-			-
Ezetimibe/Simvastatin - Tablets				-
Famotidine - Tablet	-	-	-
Golimumab - Injection For Intravenous Use	-			-
Ketoconazole - Tablet	-			-
Lomitapide Capsules	-	-		-
Lovastatin				-
Menotropins - for Injection				-
Omeprazole - Delayed-Release Capsules	-	-		-
Omeprazole - Delayed-Release Oral Suspension	-	-		-
Omeprazole/Sodium Bicarbonate - Powder for Oral Suspension	-	-		-
Palonosetron - Injection			-	-
Praziquantel Tablets	-	-
Rivaroxaban - Tablets	-	-		-
Simvastatin Tablets				-
Sitagliptin and Simvastatin - Tablets				-
Tacrolimus - Extended-Release Capsules	-
Urofollitropin - for Injection, Purified				-
VemurafenibTablets	-