MedWatch - January 2009 Safety-Related Drug Labeling Changes - Detailed

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
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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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MedWatch - January 2009 Safety-Related Drug Labeling Changes - Detailed