A new, detailed case study of a woman with diabetes is offering a close look at how the side effects of Byetta could be linked with acute pancreatitis.
The case study was published in the medical journal Endocrine Practice by doctors from the Department of Internal Medicine of Fairview General Hospital, in Westlake, Ohio, near Cleveland. The doctors say that it is the most thoroughly documented example of a case of acute pancreatitis from Byetta, which is a type 2 diabetes drug manufactured and distributed jointly by Amylin and Eli Lilly & Co.
Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.
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Learn MoreIn the new case study, doctors detailed the development of acute pancreatitis in a 64-year-old woman who did not drink or smoke, but who had diabetes and hypertension. She was prescribed Byetta about one month before she was admitted to the hospital due to gastrointestinal problems including pain and rectal bleeding. Symptoms began two days after she began taking Byetta, and she was diagnosed with pancreatitis after doctors performed a battery of tests and scans. She stopped taking Byetta just days before she was admitted to the hospital, and her condition then began to improve.
The researchers concluded that her condition was the result of a probable association with Byetta. However, the doctors indicate that they are still not sure what causes the Byetta side effect.
Concerns about pancreatitis from Byetta first surfaced in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.
Amylin and Eli Lilly currently face a number of Byetta pancreatitis lawsuits involving allegations that they failed to adequately research their medication and warn about the risk of pancreatitis from the diabetes drug.
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1 Comments
Sarah J, PhDMarch 29, 2010 at 7:29 pm
Informed reviewers know that an association between two factors does not constitute a cause. Note that the authors of the article were careful to make this distinction. It remains to be seen whether Byetta causes acute pancreatitis. There are many factors associated with its occurrence, and it is well documented that diabetics in general have a higher incidence than the population at large. The [Show More]Informed reviewers know that an association between two factors does not constitute a cause. Note that the authors of the article were careful to make this distinction. It remains to be seen whether Byetta causes acute pancreatitis. There are many factors associated with its occurrence, and it is well documented that diabetics in general have a higher incidence than the population at large. The interesting fact that you omitted in your story was that a large epidemiological study done following the 2007 reports showed that the incidence of pancreatitis among users of Byetta was actually less than the reported incidence in the population at large. This would lead to the conclusion that users of Byetta may actually be reducing their risk of pancreatitis. Note also that the FDA, which is highly concerned about the safety of any drug, deemed Exenatide safe enough to approve as monotherapy (as a stand alone treatment) last year. This was AFTER the announcements about the ASSOCIATION between use of Byetta and acute pancreatitis became suspected. Hundreds of thousands of prescriptions for Byetta have been filled. A small handful of cases of acute pancreatitis have been reported by users. It is unknown whether other factors (obesity, the use of other medications, food intake, or inherited susceptibility factors) cause acute pancreatitis in those very very few patients who experience this serious side effect. When providing information to medication users, it's always useful to provide the complete facts, so as to avoid creating unnecessary concern, which in itself may increase cortisol secretion and can have an adverse affect on certain kinds of patients.