DOC News December 1, 2007
Volume 4 Number 12 p. 5
© 2007 American Diabetes Association
Byetta alert issued
Andrew Keegan
The U.S. Food and Drug Administration has issued an advisory concerning a
possible association between use of exenatide (Byetta, Amylin/Eli Lilly) and
acute pancreatitis, saying that medical providers should be aware of the
potential connection and "instruct patients taking Byetta to seek prompt
medical care if they experience unexplained, persistent, severe abdominal
pain, which may or may not be accompanied by vomiting."
The agency is not advising physicians to discontinue use of this product,
and patients should not stop taking it without consulting a health care
provider.
Byetta is designed for use by people with type 2 diabetes who also take
metformin, sulfonylureas, or thiazolidinediones and who still need better
blood glucose control. It enhances pancreatic insulin production, slows
emptying of the stomach, and prevents the liver from making too much glucose,
all of which act to lower post-meal glucose. The drug also may suppress
appetite and result in weight loss.
There have been 30 reported cases of pancreatitis among the 700,000 people
who have used Byetta; it is not clear if the drug was the direct cause. In the
future, information about acute pancreatitis will be listed in the
"precautions" section of Byetta's product label.
Footnotes
FYI
The alert for health care professionals about exenatide is available on the
Food and Drug Administration Web site at
www.fda.gov/cder/drug/infopage/exenatide/default.htm.
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