Drug Safety Labeling Changes - February 2012

Creator: Madhumathi Palaniappan
Keywords: FDA label changes February - 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
Abatacept	-			-
Acarbose	-	-	-
Adefovir dipivoxil	-			-
Aliskiren and Amlodipine	-			-
Aliskiren and hydrochlorothiazide	-
Aliskiren and valsartan	-			-
Aliskiren, Amlodipine and Hydrochlorothiazide	-
Ambrisentan
Amlodipine, Valsartan and Hydrochlorothiazide	-
Aripiprazole	-			-
Atazanavir	-			-
Atorvastatin	-
Benazepril HCl and Hydrochlorothiazide	-
Cardiogen-82 (Rubidium Rb 82 Generator)	-			-
Conivaptan	-	-		-
Crizotinib	-			-
Darunavir	-			-
Dexamethasone Ophthalmic	-
Dextroamphetamine	-	-	-
Diovan HCT (valsartan/hydrochlorothiazide) Tablets	-
Drospirenone and Estradiol				-
Drospirenone- Estradiol- Levomefolate	-			-
Enalapril	-			-
Enalapril and Hydrochlorothiazide	-			-
Erythromycin	-	-	-	-
Erythromycin Ethylsuccinate Granules	-		-	-
Estradiol				-
Estrogen
Ezetimibe and simvastatin				-
Famciclovir	-
Fluvastatin	-
Indinavir				-
Irbesartan and Hydrochlorothiazide	-
Lapatinib	-	-		-
Lexiva (fosamprenavir calcium) tablets and oral suspension	-			-
Linezolid	-		-
Lopinavir and Ritonavir	-	-		-
Lopinavir and Ritonavir	-			-
Lovastatin
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets	-			-
Nelarabine	-	-	-
Nelfinavir				-
Niacin Er and Simvastatin
Norfloxacin	-	-	-
Olmesartan	-			-
Olopatadine Hydrochloride	-
Phendimetrazine Tartrate		-
Pitavastatin	-
Pravastatin Sodium	-
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
Rimexolone ophthalmic	-	-		-
Ritonavir	-	-		-
Rituximab	-
Rosuvastatin	-
Saquinavir	-			-
Simvastatin				-
Sitagliptin	-	-	-	-
Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution	-	-	-
Tacrolimus	-	-	-
Theophylline	-	-	-
Tipranavir	-			-
Tolvaptan	-	-		-
Valsartan	-	-