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U.S. Department of Health and Human Services

Safety

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Coumadin (warfarin sodium)

Audience: Pharmacists, other healthcare professionals, and patients
[Posted 10/06/2006] FDA and Bristol-Myers Squibb notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients.

The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. See information about all currently approved Medication Guides.
[October 2006 - Label (including Medication Guide) - Bristol-Myers Squibb]