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The January 2009 posting includes 28 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/2009/jan09_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/jan09.htm
In January 2009, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Cimzia, Avelox, Celexa, Lexapro, Cymbalta, Effexor XR, Hycodan, Nicardipine, Paxil, Pexeva, Pristiq, Prozac, Tygacil, Tyzeka, Venlafaxine, and Zoloft
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
