October 2010 Safety Labeling Changes: 34 Medical Product Labels with changes to Boxed Warnings, Contraindications, Precautions, Adverse Reactions

FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 12 Nov 2010 16:35:23 -0600 (CST)

Title: October 2010 Safety Labeling Changes: 34 Medical Product Labels with changes to Boxed Warnings, Contraindications, Precautions, Adverse Reactions

	The MedWatch October 2010 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. 

The "Summary Page" provides a listing of drug names and safety labeling sections revised: 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm230721.htm 

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information. 

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:     

Aldara (imiquimod) 

Altace (ramipril)          

Depo-Provera Contraceptive injection (medroxyprogesterone acetate)     

Enablex (darifenacin)      

Fragmin (dalteparin sodium)     

Gris-PEG (griseofulvin ultramicrosized) 

Invirase (saquinavir mesylate)     

Lamictal (lamotrigine)       

Lasix (furosemide) 

Letairis (ambrisentan)      

Myfortic(mycophenolic acid) 

Nexavar (sorafenib tosylate)      

Nuvigil (armodafinil)        

Precedex (dexmedetomidine hydrochloride)      

Procardia XL (nifedipine)   

Provigil (modafinil)      

Rebetol (ribavirin)        

Rythmol SR (propafenone hydrochloride) extended-release capsules

Sprycel (dasatinib) 

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