On August 26, 2008, company officials for Amylin Pharmaceuticals, Inc. reported four additional deaths in Byetta patients, bringing the total number of patient deaths after developing pancreatitis to six. Earlier in the month, the Food and Drug Administration (FDA) reported two Byetta patient deaths and four hospitalizations; the four additional deaths are not connected to the four hospitalizations.

Co-marketed by Amylin and Eli Lilly, Byetta is an injected medication used to treat type 2 diabetes in adults. It was approved in 2005, and is used to improve blood sugar control. It can be combined with other diabetes drugs, but the recent reports of patient deaths have some questioning whether it should be used as a monotherapy.

The first two deaths reported by the FDA were attributed to hemorrhagic pancreatitis or necrotizing pancreatitis. Of the four additional deaths, one died from complications of gallbladder removal, one died from a relapse of leukemia, and a third died from intestinal bleeding after gallbladder removal; the cause of death for the fourth patient is not yet known.

Eli Lilly’s vice president of global patient safety said the prescribing information for Byetta has included information about pancreatitis since 2006, and this prescribing information was amended in 2007 to list pancreatitis as a precaution. Also in 2007, doctors were alerted about the potential for pancreatitis in Byetta patients.

While Byetta has not been identified as a cause for pancreatitis, analysts suspect an association between the drug and the disease. Type 2 diabetes patients have almost three times the risk of developing pancreatitis than the general population. But as of now, doctors believe the benefits of Byetta outweigh the risks.

Officials from Amylin and Eli Lilly are working with the FDA to decide on possible changes to Byetta’s warning label. Some executives have said the advisory could be upgraded to a higher warning, which may include the FDA’s strictest warning, the black box.

The surge of bad news for Byetta could have an effect on the approval of Byetta LAR, a once-weekly formulation currently in development. Eli Lilly, Amylin and Alkermes Inc. are expected to file for approval of the formulation in 2009.

Sources: Elizabeth Trotta, “Byetta talk leads Amylin to fall further,” TheStreet.com, August 27, 2008; Thomas Gryta, “UPDATE: Byetta concerns stoke worries for once-weekly version,” CNNMoney, August 27, 2008; Kathleen Doheny, “6 deaths reported from diabetes drug Byetta,” WebMD.com, August 27, 2008.