Drug Safety Labeling Changes - November 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes November - 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
Duloxetine - Delayed-Release Capsules	-			-
Fluticasone Propionate and Salmeterol Xinafoate - Inhalation Powder, Advair HFA Inhalation Aerosol	-	-	-
Montelukast - Tablets, Chewable Tablets and Oral Granules	-	-	-
Pazopanib - Tablets	-			-
Ambenonium Chloride - Tablets	-	-
Ampicillin /Sulbactam - Injection			-
Bosutinib - Tablets	-			-
Brentuximab Vedotin - for Injection	-			-
Cinacalcet -Tablets	-
Daptomycin - For Injection Intravenous	-			-
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), Depakote ER (divalproex sodium) Extended Release Tablets	-	-	-
Diltiazem - Tablets	-	-
Docetaxel - Injection Concentrate	-			-
Flovent HFA - Inhalation Aerosol	-	-	-
Fluticasone Propionate - Inhalation Powder	-	-	-
Foscarnet - Injection	-	-
Gadodiamide - Injection, Gadodiamide - Pharmacy Bulk Package Injection	-	-	-
Gemfibrozil - Tablets	-			-
Leflunomide - Tablets
Moxifloxacin Hydrochloride - 400 mg Tablets and Moxifloxacin Hydrochloride in Sodium Chloride Injection) IV	-			-
Nitrofurantoin - Oral Suspension	-	-	-
OptiMARK Injection, OptiMARK in Plastic Container, OptiMARK Pharmacy Bulk Package Injection	-	-	-
Peginterferon alfa-2b	-	-		-
Rifabutin - Capsules	-	-
Sofosbuvir -Tablet	-			-
Tapentadol - Oral Solution	-	-	-
Tocilizumab	-	-	-
Valproate Sodium Injection	-	-	-
Valproic Acid - Capsules and Oral Solution	-	-	-
Vemurafenib - Tablet	-