Drug Safety Labeling Changes - April 2012

Creator: Madhumathi Palaniappan
Keywords: FDA label changes April - 2012, 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
Advicor (Niacin Extended-release/Lovastatin) Tablets				-
Aliskiren
Aliskiren and Amlodipine
Aliskiren and hydrochlorothiazide
Aliskiren and valsartan				-
Aliskiren, Amlodipine and Hydrochlorothiazide
Boceprevir	-	-		-
Calcitonin- Salmon	-	-	-
Candesartan	-			-
Certolizumab	-			-
Denosumab	-			-
Drospirenone and Estradiol	-			-
Drospirenone- Estradiol- Levomefolate	-			-
Erlotinib	-			-
Estradiol				-
Estrogen			-	-
Everolimus	-			-
Finasteride	-	-	-
Histrelin acetate	-	-	-
Iloprost	-	-	-
Insulin Detemir	-
Itraconazole				-
Levofloxacin	-			-
Liraglutide [rDNA] Injection	-
Lovastatin
Megestrol	-	-		-
Nelfinavir				-
Omeprazole and Sodium Bicarbonate	-			-
Palivizumab	-
Paroxetine	-	-	-
Pazopanib	-			-
Pegloticase	-			-
Perindopril	-			-
Ramipril	-			-
Repaglinide and Metformin	-			-
Rituximab	-	-	-
Rotigotine	-			-
Somatropin	-
Sunitinib	-
Terbinafine	-	-	-