Drug Safety Labeling Changes - June 2012

Creator: Madhumathi Palaniappan
Keywords: FDA label changes June - 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
Albuterol (Salbutamol)	-	-	-
Atomoxetine
Azithromycin	-			-
Bendamustine hydrochloride	-	-		-
Bepotastine		-	-
Darunavir	-
Desogestrel and Ethinyl Estradiol	-	-		-
Dopamine	-	-	-
Dutasteride	-			-
Dutasteride And Tamsulosin	-			-
Efavirenz	-			-
Estradiol				-
Helidac Therapy (bismuth subsalicylate, metronidazole tablet and tetracycline hydrochloride) capsule	-		-
Interferon Alpha- Two B	-	-	-	-
Lisinopril	-			-
Mecasermin [rDNA origin] Injection	-	-	-
Methergine (methylergonovine maleate) tablet and injection	-
Modicon (norethindrone/ethinyl estradiol)	-	-		-
Mycophenolatemofetil	-			-
Myfortic (mycophenolic acid) delayed-release tablets	-			-
Norfloxacin	-	-	-
Norgestimate and ethinyl estradiol	-	-		-
Noxafil (posaconazole) Oral Suspension		-	-	-
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets	-	-		-
Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablet	-	-		-
Ortho-Novum (norethindrone/ethinyl estradiol) 1/35 Tablets	-	-		-
Ortho-Novum (norethindrone/ethinyl estradiol) 7/7/7 Tablets	-	-		-
Peginterferon Alfa 2 B	-	-	-	-
Pemetrexed	-	-	-
Privigen Immune Globulin Intravenous (Human) 10% Liquid	-			-
Solifenacin	-			-
Telaprevir	-			-
Ustekinumab				-
Verteporfin	-	-
Zileuton	-	-		-