Raulken co.UK - FDA Notes 2 More Byetta Deaths

By Miranda Hitti Aug. 18, 2008 -- The FDA today said it plans to strengthen warnings about life-threatening pancreas problems linked to the type 2 diabetes drug Byetta after getting two more reports of deaths and four other hospitalizations in Byetta...

SHARE RSS The diabetes drug Byetta, marketed by drugmakers Eli Lilly and Amylin Pharmaceuticals, has come under increased scrutiny by federal regulators as a number of deaths have been reported with the drug. (newscom) Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths were reported with the medication despite earlier government warnings. The Food and Drug Administration said Monday it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering. Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition. The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. None of those cases were fatal, but Byetta's makers agreed to add information about the reports to the drug's label. However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks. Amylin and Eli Lilly said in a statement that...
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