August 2008 – Six patients taking the type 2 diabetes drug Byetta are reported to have died after developing severe cases of pancreatitis, according to officials from Amylin Pharmaceuticals and Eli Lily & Company, the companies that co-market Byetta.

On August 18, the FDA reported two deaths and four hospitalizations in Byetta patients who had pancreatitis. The six patients at the center of the FDA announcement all had either hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) or necrotizing pancreatitis (an inflamed pancreas that destroys itself).

All six patients were hospitalized and their Byetta treatment was discontinued, but two patients did not survive. The four survivors were still recovering when the FDA made its announcement. The four additional deaths, which were reported later by company officials, are not connected with the four survivors announced by the FDA.

The link between Byetta and pancreatitis has been known since October 2007, when the FDA issued a press release stating that it had received 30 reports of acute pancreatitis, which is sudden inflammation of the pancreas, in Byetta patients. However, none of those Byetta patients had hemorrhagic or necrotizing pancreatitis, which are much more serious forms of pancreatitis.

At the time, Amylin agreed to add information about acute pancreatitis to the “precautions” section of Byetta’s label. Now, the FDA says it is working with Amylin to add additional warnings to Byetta’s label. Specifically, the FDA plans to strengthen and draw attention to warnings about acute hemorrhagic or necrotizing pancreatitis.

Byetta, a twice daily injectable of the GLP-1 class of drugs, was approved by the FDA in 2005. Typically prescribed by a specialist to patients with advanced type 2 diabetes, Byetta helps improve blood sugar and may help with weight loss and appetite suppression. Although Amylin Pharmaceuticals and Eli Lily & Company admit that Byetta carries a pancreatitis risk in “rare” cases, the companies say Byetta’s benefits still outweigh the risks. 

Still, the FDA says that Byetta and other suspect drugs should be promptly discontinued if pancreatitis is suspected. Additionally, Byetta should not be restarted if pancreatitis is confirmed.

Injured By Byetta?

If you or a loved took Byetta and suffered a serious side effect, such as pancreatitis, you may be entitled to compensation. Please contact us today for a confidential and free assessment of your legal rights.

Published November 17, 2011 by