Yesterday, drug makers Amylin Pharmaceuticals Inc. and Eli Lilly & Co revealed that the diabetes drug Byetta had been associated with four more deaths in patients with pancreatitis. Those deaths were not included in a Food & Drug Administration (FDA) notice released last week that revealed two other Byetta-related pancreatitis deaths.
Byetta was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.
Last October, the FDA said that 30 people developed pancreatitis that was associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.
Then last week, the FDA said that it had received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
While all of the newly revealed fatalities involved patients who had pancreatitis, a report in “US News and World Report” said the FDA did not include the four in its earlier announcement because they involved a milder form of the disorder. No definite relationship between Byetta and the additional deaths has been proved, Amylin Chief Executive Officer Dan Bradbury said during a conference call yesterday.
