Byetta® Type 2 Diabetes
Injectable Drug
Byetta® was approved by the FDA (Food and Drug Administration) in 2005 for use by adults
with type 2 diabetes. Made
by Amylin Pharmaceuticals, Inc., Byetta® is a subcutaneous injectable medication
that comes in a pre-filled pen, and is used to control blood sugar for type
2 diabetes. Byetta® is in a class of medications called incretin mimetics,
which essentially mimic incretins, the natural hormones in the body that
lower blood sugar. It enables the pancreas to release insulin, and lowers
blood sugar levels when they become too high. It also prevents the pancreas
from releasing glucagon, a hormone that causes the liver to release stored
sugar into the blood stream.In October of 2007, the FDA issued an alert after reviewing 30 reports of acute pancreatitis in patients taking Byetta®. This alert urged healthcare professionals to “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 alert went on to say that, “If pancreatitis is suspected, Byetta® should be discontinued. If pancreatitis is confirmed, Byetta® should not be restarted unless an alternative etiology is identified.”
At the FDA’s request, Amylin Pharmaceuticals, Inc. agreed to include information about acute pancreatitis on the product label.
Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection, and in some cases, can be fatal. Of the thirty patients reported with acute pancreatitis, five developed additional complications such as kidney failure. Twenty-two of the patients improved after discontinuing Byetta®.
In its August 18, 2008 update to this alert, the FDA stated that it had received reports of six cases of hemorrhagic or necrotizing pancreatitis. All of these patients were hospitalized, two died and four were recovering.
If someone you care about has been taking Byetta® and experienced persistent, severe abdominal pain or died as a result, please fill out our Case Review Form to the right on this page for a free consultation.
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