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The MedWatch May 2010 Drug Safety Labeling Changes posting includes 23 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/ucm214902.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 CONTRAINDICATIONS and WARNINGS sections:
Camptosar (irinotecan HCl)
Cervidil (dinoprostone)
Droxia and Hydrea (hydroxyurea)
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin])
Parnate (tranylcypromine sulfate)
PrandiMet (repaglinide/metformin HCl fixed-dose combination)
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine)
Selzentry (maraviroc)
Tekturna HCT (aliskiren/hydrochlorothiazide)
Vaprisol (conivaptan)
Zyprexa (olanzapine)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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