Drug Safety Labeling Changes - April 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes April - 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
	-
Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) Tablets, Caplets and Geltabs	-		-	-
Buprenorphine and Naloxone - Sublingual Film	-			-
Clindamycin - Lotion, Solution, and Gel, 1 Percent	-	-		-
Fingolimod	-			-
Hydromorphone - Extended-Release Capsules	-			-
Hydromorphone -Extended-Release Tablets	-			-
Morphine - Extended-Release Capsules	-			-
Nitroglycerin - USP 0.3, 0.4, 0.6 mg Sublingual Tablets	-	-		-
Pegaspargase	-
Sapropterin Dihydrochloride	-			-
125 Phenytoin - Oral Suspension and Phenytoin Injection	-	-		-
Acyclovir 5 Percent Cream	-	-	-	-
Alfuzosin - Extended Release Tablets	-	-	-
Avanafil	-			-
Azilsartan Medoxomil - 40 mg and 80 mg Tablets	-	-	-
Azilsartan Medoxomil and Chlorthalidone - 40 mg/12.5 mg and 40/25 mg Tablets	-	-	-
Belimumab	-			-
Buprenorphine -Transdermal System	-			-
Darunavir - tablets, 75 mg, 150 mg, 600 mg, and 800 mg Darunavir - oral suspension, 100 mg/mL	-			-
Dasatinib - 20, 50, 70, 80, 100 and 140 mg Tablets	-			-
Delflex Peritoneal Dialysis (PD) Solutions (1.5%, 2.5% and 4.25% Dextrose with Standard Calcium/Standard Magnesium and with Standard Calcium/Low Magnesium) Delflex PD Solutions (1.5%, 2.5% and 4.25% Dextrose with Low Calcium/Low Magnesium)	-			-
Desloratadine - Tablets, Desloratadine - Oral Solution, Desloratadine - Reditabs	-	-	-
Docetaxel - Injection Solution for Intravenous Infusion, 10 mg/mL, 20 mg/12mL, 80 mg/8mL, and 160 mg/16mL	-	-	-
Erlotinib - Tablets, 25mg, 100mg and 150mg	-
Fentanyl - Transdermal System	-			-
Iloperidone - 1, 2, 4, 6, 8, 10, and 12 mg tablets	-	-		-
Interferon beta-1a Injection	-	-	-
Ketorolac - Nasal Spray	-	-		-
Lovastatin - Extended-Release Tablets; 20, 40, and 60 mg	-	-	-
Methadone - Tablets	-			-
Mometasone Furoate and Formoterol Fumarate - Inhalation Aerosol	-	-		-
Morphine - Extended-Release Capsules	-			-
Morphine - Extended-Release Tablets	-			-
Morphine and Naltrexone - Extended-Release Capsules	-			-
Oxycodone - Extended-Release Tablets	-			-
Oxymorphone - Extended-Release Tablets	-			-
Paliperidone - Tablets, and Paliperidone - Extended-Release Suspension for Intramuscular Injection	-	-
Pentoxifylline - Extended-Release Tablets, 400 mg	-	-		-
Raltegravir - film-coated tablets, 400 mg Raltegravir - chewable tablets, 25 mg, 100 mg Raltegravir - for oral suspension, 100 mg	-	-		-
Risperidone -Tablets Risperidone - Oral Solution Risperidone - Orally Disintegrating Tablets Risperidone Long Acting Injection	-	-	-
Sodium Oxybate - Oral Solution	-	-		-
Tadalafil - 20 mg Tablets	-	-
Tadalafil - Tablets 5 mg	-	-	-	-
Tapentadol - Extended-Release Tablets	-			-
Temsirolimus - Injection, 25 mg/mL	-
Tipranavir - Capsules, 250 mg, Tipranavir - Oral Solution, 100 mg/mL		-		-
Tobramycin - Inhalation Powder for Oral Inhalation, 28 mg	-	-
Tobramycin - Inhalation Solution, USP 300 mg/5mL	-	-		-
Vardenafil - Orally Disintegrating Tablets	-			-
Vardenafil - Tablets	-			-
Vilazodone Hydrochloride - 10 mg, 20 mg, and 40 mg Tablets	-
Voriconazole - Tablets Voriconazole - for Injection Voriconazole - for Oral Suspension		-		-
Zoledronic Acid - Injection, 4 mg/100 mL single-use,ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate	-