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The December 2008 posting includes 50 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2008/dec08_quickview.htm
The "Detailed View Page" 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:
http://www.fda.gov/medwatch/safety/2008/dec08.htm
In December 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Avandamet, Avandaryl, Myozyme, Arimidex, Avelox, Celebrex, Children's Advil Cold, Crixivan, Delsym, Dianeal, Ethyol, Innohep, Lipofen, OMNICEF, Rifater and Sensipar
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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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
