The Food and Drug Administration issued a warning in August 2008 of a link between the diabetes drug Byetta (exenatide) and a serious and potentially deadly form of pancreatitis. The agency states that it has received reports of at least 36 cases of pancreatitis among patients taking Byetta, including at least six cases involving a form of the disease known as hemorrhagic or necrotizing pancreatitis.
Byetta is prescribed in order to treat the symptoms of type 2 diabetes in patients who don’t respond to other forms of treatment. More than 700,000 patients have taken Byetta since it was first released in June 2005 by Amylin Pharmaceuticals and Eli Lilly & Co.
Concerns about the risk of Byetta side effects first arose in October 2007, after the FDA received reports of at least 30 patients who developed acute pancreatitis after taking the diabetes drug. In response to these reports, the FDA issued a Byetta warning about a potential link between the drug and pancreatitis. The agency also instructed Amylin to add information about pancreatitis to the precautions section of the drug’s label, which lists some of the potential Byetta side effects.
In August 2008, the FDA issued a second Byetta warning after learning of six more serious pancreatitis cases among patients who were taking the drug. All six of these Byetta pancreatitis cases required the patients to be hospitalized for hemorrhagic or necrotizing pancreatitis; at least two later died as a result of their illnesses.
Based on these reports, the FDA said that it would work with Amylin to add a stronger Byetta warning to the drug’s labeling in order to alert doctors and patients about the risk of pancreatitis from taking the drug. Amylin later reported four additional Byetta deaths among patients taking the drug; however, there is currently no indication that the FDA plans to issue a Byetta recall based on these cases.
The first Byetta lawsuit was filed by a Virginia man who developed pancreatitis after taking the diabetes drug. The lawsuit alleges that Byetta was the cause of the man’s illness, and that Amylin did not do enough to warn the public about the link between Byetta and pancreatitis. The man’s Byetta attorney stated that he believes that Amylin may have had evidence as early as 2007 about the drug’s side effects that would have justified adding a stronger warning label.
If you or someone you know has developed pancreatitis or other Byetta side effects, contact the office of Hissey Kientz by calling toll-free at (866) 275-4454 for information about your legal rights or fill out a free online evaluation on the top right of this page.