miércoles, 26 de agosto de 2009
Drug Safety Labeling Changes by FDA
The MedWatch July 2009 Drug Safety Labeling Changes posting includes 38 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/ucm172740.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:
Chantix (varenicline), Wellbutrin (bupropion hydrochloride), Zyban (bupropion hydrochloride), Diabeta (glyburide), Lopid (gemfibrozil), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine, Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), Soliris (eculizumab)
Publicado por salud equitativa en 14:43
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