The FDA announced on Monday that it is working with Amylin and Eli Lilly to issue stronger warnings about the safety of Byetta, a drug used in the treatment of Type II diabetes. The warnings were prompted by six recently reported cases of severe pancreatitis, two of which resulted in deaths. Late Tuesday, Amylin and Eli Lilly announced another four deaths of patients taking Byetta. Currently, over 1 million prescriptions have been written for the drug, and sales account for over 80% of Amylin’s revenue.
Byetta (exenatide) is currently the only drug on the market classified as an incretin mimetic. When a person consumes food, the body releases a hormone that affects functions in the pancreas, brain, intestine, and liver, to aid digestion and regulate blood sugar. Exenatide is intended to mimic this hormone. The drug is administered as an injectable, twice daily. Amylin is currently working toward approval on a “Long Acting” version.
According to this press release, recent studies have shown that people diagnosed with Type II diabetes are at higher risk of pancreatitis. Although no causal link has been proven between the use of Byetta and pancreatitis, those taking the drug may want to consult with their health care providers.
