Several deaths were reported with the medication of diabetes drug, Byetta, marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co.
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.
Byetta competes against blockbuster drugs from GlaxoSmithKline PLC and Takeda Pharmaceuticals in the $24 billion global market for diabetes medications, according to health care research firm IMS Health.
More than 700,000 patients with type 2 diabetes have used the injectable drug since it was launched in June 2005.
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