September 2009: Drug Safety Labeling Changes

September 2009
Drug Safety Labeling Changes
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING,
C=CONTRAINDICATIONS,
W=WARNINGS,
P=PRECAUTIONS,
AR=ADVERSE REACTIONS,
PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

The MedWatch September 2009 Drug Safety Labeling Changes posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, 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/ucm183107.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 to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
AndroGel (testosterone gel), Rapamune (sirolimus), Testim (testosterone gel), Cordarone (amiodarone HCl), Flector Patch (diclofenac epolamine), Intelence (etravirine), Kayexalate (sodium polystyrene sulfonate), Lexiva (fosamprenavir calcium), Neoral (cyclosporine capsules, modified), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Pre-Pen (benzylpenicilloyl polylysine), Sustiva (efavirenz), Ultracet (tramadol HCl/acetaminophen), Ultram (tramadol hydrochloride), Voltaren Gel (diclofenac sodium), Zolinza (vorinostat).

abrir aquí para acceder al documento FDA completo:
September 2009