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Byetta Linked to More Deaths

Aug 27, 2008 | Parker Waichman Alonso LLP

Byetta has been implicated in six deaths, four more than federal regulators reported last week.  The additional deaths were revealed late yesterday during a conference call conducted by Amylin Pharmaceuticals Inc. and Eli Lilly & Co, the co-marketers of the diabetes drugs.  The companies did report the other four deaths to the Food & Drug Administration (FDA), but the agency did not make those fatalities public in last week's announcement.

No definite relationship between Byetta and the additional deaths has been proved, Amylin Chief Executive Officer Dan Bradbury said during the call yesterday.  All of the deaths involved patients with pancreatitis, but according to a report in "US News and World Report", the FDA did not include the four revealed yesterday in its earlier announcement because they involved a milder form of the disorder.

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.

Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs. In some instances, acute pancreatitis can be fatal. Hemorrhagic pancreatitis is inflammation that involves bleeding.  Necrotizing pancreatitis occurs when the inflamed pancreas destroys itself.

The FDA said last week it was working with  Eli Lilly and Amylin to add stronger and more prominent warnings to Byetta's label. That could include upgrading a current precaution on pancreatitis to a warning, or changing the wording.

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.