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The March 2009 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/medwatch/safety/2009/mar09_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/2009/mar09.htm
The following 19 drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Epzicom, OsmoPrep, Raptiva, Sporanox, Trizivir, Visicol, Diabeta, Macrobid, Macrodantin, Rocephin, Theophylline, Tracleer, Advair, Altace, Axert, Cymbalta, Frova, Lexiscan, and Spiriva
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
