Drug Safety Labeling Changes - SEPTEMBER 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes SEPTEMBER - 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
Ofatumumab - Injection	-			-
Pemetrexed for Injection for intravenous use, 100 mg and 500 mg vials	-	-	-
10% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container	-	-
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container	-	-
5% Dextrose and 0.2% Sodium Chloride Injection, USP in Plastic Container	-	-
5% Dextrose and 0.33% Sodium Chloride Injection, USP in Plastic Container	-	-
5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container	-	-
5% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container	-	-
Axitinib tablets	-	-	-
Boceprevir - 200 mg capsules	-	-		-
Bosutinib - Tablets, 100 mg and 500 mg	-	-		-
Clarithromycin - Tablets, USP Clarithromycin - for Oral Suspension, USPClarithromycin - Extended Release Tablets	-			-
Clopidogrel - 75 mg Tablets	-
Desflurane				-
Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride Injections	-	-
Dolasetron Mesylate	-	-
Doxycycline Monohydrate for Oral Suspension Doxycycline Hyclate Capsules, USP Capsules Doxycycline Calcium Oral Suspension Syrup Doxycycline HyclateTablets, USP Film Coated Tablets	-	-
Doxylamine - Tablets, 25mg	-		-	-
Estradiol/Norethindrone acetate transdermal system
Ezogabine tablets 50 mg, 200 mg, 300 mg, 400 mg	-			-
Filgrastim	-	-
Fluconazole - IV	-	-		-
Fluconazole - Powder for Oral Suspension	-	-		-
Fluconazole -Tablets	-	-		-
Fondaparinux - Injection		-	-
Gemcitabine - Injection 38 mg/mL	-			-
Golytely (PEG 3350 and electrolytes) for Oral Solution, 1 Gallon and 4 Liter	-			-
Hydroxyprogesterone Caproate Injection - 250ml/mg	-	-
Insulin glulisine [rDNA origin] injection	-			-
Lacosamide - Injection	-	-	-	-
Lacosamide - Oral Solution	-	-	-	-
Lacosamide -Tablets	-
Levalbuterol - Inhalation Aerosol	-	-	-
Levonorgestrel-Releasing Intrauterine System	-	-	-	-
Linagliptin and Metformin Hydrochloride - Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg	-			-
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution)	-	-		-
Mycophenolate mofetil	-		-	-
Mycophenolic Acid - Delayed-Release Tablets	-			-
Nilotinib - capsules, 150 mg and 200 mg	-			-
Nitrofurantoin - 75 mg/Nitrofurantoin Macrocrystals - 25 mg Capsules	-	-	-
Nitrofurantoin Macrocrystals Capsules	-	-	-
Nulytely (PEG 3350 and electrolytes) for Oral Solution	-			-
Piperacillin / Tazobactam - for injection, USP	-
Piperacillin /Tazobactam - injection in Galaxy Containers (PL 2040 Plastic)	-
Plasma-Lyte 148 and Plasma-Lyte A pH 7.4 (Multiple Electrolytes, Type 1, USP) Injection
Potassium Chloride in Dextrose 5% and Sodium Chloride Injections	-	-
Quinapril - 5 mg, 10 mg, 20 mg, and 40 mg Tablets				-
Quinapril - Hydrochlorothiazide - 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets				-
Ramipril -1.25 mg, 2.5 mg, 5 mg, and 10 mg				-
Rituximab	-			-
Sitagliptin and Metformin HCl -tablets, 50 mg/ 500 mg and 50 mg/ 1000 mg
Tacrolimus - Capsules, 0.5 mg, 1 mg, and 5 mg Tacrolimus - Injection, 5 mg/ml	-
Terconazole - Vaginal Cream, 0.4%	-		-
Terconazole - Vaginal Suppositories, 80 mg	-		-
Terconazole- Vaginal Cream, 0.8%	-		-
Testosterone Gel	-	-	-	-
Tigecycline - for Injection	-
Tobramycin inhalation solution, USP 300mg/5mL	-	-
Treprostinil - 20 mg, 50 mg, 100 mg, and 200 mg for Injection	-
Trimethoprim and Sulfamethoxazole - Tablets
Zoledronic Acid - Injection, 4 mg/100 mL single-use ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate	-			-