In a conference call late Monday, Eli Lilly & Co. and Amylin Pharmaceuticals, Inc. indicated that they have notified the FDA about four more deaths from pancreatitis among users of their diabetes drug Byetta. These four cases are in addition to two other Byetta pancreatitis deaths the FDA referenced in a notice to healthcare providers issued last week.
Byetta (exenatide) is a subcutaneous injection given twice a day to persons with Type-2 diabetes to lower their blood sugar levels. Since it was approved in the United States in April 2005, it has been used by about 1 million people.
Although sales of the drug grew 17 percent in the second quarter this year as compared to the same period last year, concerns have grown recently among users and prescribers about a possible Byetta side effect which could increase the risk of pancreatitis.
On August 18, 2008, the FDA posted an alert on their website to notify doctors that the agency had received reports of at least six cases of necrotizing pancreatitis or hemorrhagic pancreatitis associated with Byetta. The FDA indicated that two of those six had died as a result of the severe cases of acute pancreatitis, and the other four were recovering.
Following the close of the U.S. markets on Monday, Eli Lilly and Amylin, who jointly market Byetta, held a conference call for the media, investors and the general public to discuss the possible association between Byetta and pancreatitis. At that time, the drug makers indicated that they had also notified the FDA of at least four other pancreatitis deaths among users of Byetta. However, they suggested that they do not believe there is any definite relationship between the drug and the deaths.
Eli Lilly and Amylin are in talks with the FDA about the possibility of new warnings about the Byetta pancreatitis risks. There are indications from some financial analysts that Byetta could receive a “black box” warning, which is the strongest warning issued by the FDA. The company did not disclose details regarding when the label change could take effect.
If a “black box” warning about pancreatitis is placed prominently on the Byetta label, it will likely cause a substantial drop in sales for Byetta, which is a big seller for the manufacturers. It could also reduce the chances that the FDA will approve a newer, longer acting version of the drug which is only injected once a week.
The drug makers will also likely face an increasing number of Byetta lawsuits from users who suffer pancreatitis after taking the drug.
The first known Byetta pancreatitis lawsuit has already been filed in California state court, coming only a few days after the FDA’s alert last week.