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Article: Black Box Warning Label Added to Valproate Products.
- Article from:
- Family Practice News
- Article date:
- October 1, 2000
- Author:
CopyrightCOPYRIGHT 2000 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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A black box warning about the possibility of life-threatening pancreatitis has been added to the labels of Depakote, Depakene, and Depacon.
Although the package inserts of all valproate products have mentioned pancreatitis since 1981 and there has been no increase in the number of reported cases of pancreatitis associated with valproate use, Abbott Laboratories and the Food and Drug Administration revised the label to include additional information, according to an Abbott statement.
Cases of life-threatening pancreatitis have been reported in both children and ...