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.

Nov 29, 2010

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.

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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