Drug Safety Labeling Changes - July 2012

Creator: Madhumathi Palaniappan
Keywords: FDA label changes July - 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
Abiraterone acetate	-	-	-
Aldesleukin	-	-	-
Alglucosidase	-	-	-
Anidulafungin	-			-
Atomoxetine	-			-
Azithromycin		-	-	-
Beclomethasone Dipropionate	-	-
Boceprevir	-	-		-
Buprenorphine				-
Caduet (amlodipine/atorvastatin) Tablets	-
Clarithromycin
Colesevelam Hcl	-	-	-
Dantrolene	-
Desogestrel and Ethinyl Estradiol	-	-		-
Dexrazoxane	-			-
Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)
Fentanyl Skin Patches				-
Flurbiprofen	-	-	-
Fulvestrant	-	-	-
Hydromorphone				-
Leuprolide	-	-	-
Methadone				-
Morphine				-
Morphine Sulfate and Naltrexone Hydrochloride				-
Nesiritide	-
Oxycodone Hydrochloride				-
Oxymorphone				-
Peginterferon Alfa 2 B	-	-		-
Pegvisomant	-	-
Pentoxifylline	-	-
Pramipexole	-
Solifenacin	-	-	-
Tacrolimus	-
Tapentadol				-
Thyrotropin Alfa	-	-
Trospium	-
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets				-