The FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta.

Update Aug. 27 The makers of the type 2 diabetes drug Byetta reported Tuesday the deaths of four more people who’d been taking the medication.

Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis.

The FDA is warning patients taking Byetta that there have been “very rare case reports of pancreatitis with complications or with a fatal outcome.”

Six more reports of patients developing pancreatitis while taking Byetta. Two patients died and 4 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. At that time 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 patients taking Byetta have shown “very rare case reports of pancreatitis with complications or with a fatal outcome.” The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.

The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.

If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Read the complete MedWatch 2008 Safety Summary, including a link to the ‘”Information for Healthcare Professionals”

Byetta Lawyers are available for free consultations for people who have been affected by the side effects of this drug.

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