Diabetes Drug Linked to Potentially Fatal Pancreatitis

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October 17th, 2007

"Byetta Linked to Acute Pancreatitis"

The diabetes drug Byetta has been linked to acute pancreatitis, a potentially fatal condition in which the pancreas becomes inflamed, according to a new Food and Drug Administration warning.

About Byetta

Byetta gained FDA approval for use in the treatment of type 2 diabetes in 2005 and has since been used by 700,000 patients in the United States. The drug is administered by way of injection twice a day and helps to regulate blood sugar levels.

Now, post-marketing reports of Byetta are raising concerns about the risk of acute pancreatitis. The FDA said it has received 30 reports of the condition in patients using the drug, which is marketed by Eli Lilly and Amylin Pharmaceuticals.

Labeling Updated

An Amylin spokeswoman said Byetta's labeling would be updated to reflect the new information and provide patients and doctors with a clear set of signs and symptoms to watch out for.

“It's a rare but serious event,” said Amylin spokeswoman Alice Bahner Izzo.

Acute pancreatitis can only be confirmed with tests, but the FDA said patients should look out for the following symptoms:

  • Severe and persistent abdominal pain
  • Nausea
  • Vomiting

Although abdominal discomfort, nausea and vomiting are common side effects of the drug, the agency said they become more severe with acute pancreatitis. Patients who suspect the condition should stop taking the drug immediately and consult a physician.

(Source: Wall Street Journal online)

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