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The MedWatch October 2009 Drug Safety Labeling Changes posting includes 26 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/ucm187420.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:
Azulfidine (sulfasalazine), Lotrel (amlodipine besylate/benazepril hydrochloride), CellCept (mycophenolate mofetil), Hepsera (adefovir dipivoxil), Invanz (ertapenem), Invega (paliperidone), Ixempra kit (ixabepilone), MultiHance (gadobenate dimeglumine), Myfortic (mycophenolic acid), Neoral (cyclosporine), Norpramin (desipramine hydrochloride), Pulmicort Respules (budesonide), Rapamune (sirolimus), Sandimmune (cyclosporine), Viread (tenofovir disoproxil fumarate)
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