Is Byetta's Manufacturer Pushing the Envelope?

STOCKHOLMSince the FDA's approval of Byetta (the first commercial product based on GLP-1) in May 2005, manufacturers Amylin Pharmaceuticals and Eli Lilly & Co. have been working hard to ensure that its diabetes drug reaps profits, which is likely a challenge for the giant pharmaceutical company, particularly since Byetta has been associated with acute pancreatitis.

According to medpagetoday.com, researchers from the European Association for the Study of Diabetes met recently in Stockholm. "Giving exenatide (Byetta) to patients who aren't fully controlled with insulin glargine and other oral agents improves their blood glucose," they said. However, this is the first trial using a GLP-1 receptor agonist with basal insulin, which has not yet been approved in the US or Europe.

Yet the study, which was supported by Eli Lilly and Amylin, advises clinicians to "explain to interested patients that giving exenatide (Byetta) to patients who aren't fully controlled with insulin glargine and other oral agents improves their blood glucose."
The researchers in this trial assessed a total of 259 patientsProzac marketing scheme.

And now there is Byetta. A lawsuit has been filed against Eli Lilly and Amylin for failing to adequately test the drug before it was released into the marketplace. The lawsuit alleges that the manufacturers failed to adequately monitor patients using the drug or inform doctors and patients of the serious risk of developing pancreatitis.

(The medpagetoday.com article mentioned above was reviewed by Robert Jasmer, MD., Associate Clinical Professor of Medicine, University of California, San Francisco. Interestingly, The University of California, San Francisco receives funding from Eli Lilly and Amylin. As well, Dr. Jasmer recently published "Treatment of Tuberculosis" guidelines; Eli Lilly is also a major funder of tuberculosis research.)

Important Safety Information for BYETTA (exenatide) injection includes the following:

"Based on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis…. The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time… These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away."

(Some Byetta patients have reported to lawyersandsettlements that nausea was the precursor to pancreatitis.)