Aug. 27, 2008 -- Six patients taking the type 2 diabetes drug Byetta are reported to have died after developing pancreatitis. That's according to officials from Amylin Parmaceuticals and Eli Lily & Company, the companies that co-market the drug.
Last week, the FDA reported two deaths and four hospitalizations in Byetta patients who had pancreatitis. The four additional deaths -- announced Tuesday by company officials -- are not connected with the four hospitalizations announced by the FDA. Last week, the FDA also said it plans to strengthen warnings about serious pancreatitis problems linked to the drug.
Byetta, an injected medication, was approved by the FDA in 2005. It is used to improve blood sugar control and can be combined with other diabetes drugs. Company officials say benefits of the drug still outweigh the risks.
Last week, the FDA said two patients who died had hemorrhagic pancreatitis, in which the pancreas is inflamed and bleeding, or necrotizing pancreatitis, in which there is inflammation and tissue death, with the pancreas destroying itself. The pancreas makes pancreatic juices and hormones, including insulin.
Orville Kolterman, MD, Amylin's senior vice president of research and development, says one of the two deaths reported last week by the FDA involved a morbidly obese patient who weighed more than 400 pounds and who had extensive gallstones at autopsy.
"In the second case [reported Aug.18], death was due to a complicated medical course that included necrotizing pancreatitis," according to Kolterman. He says the patient had stopped taking Byetta some months before being hospitalized.
Of the other four deaths, Kolterman says, the cause of death is not yet known in one. In the other three, one patient appears to have died from complications of gallbladder removal, another from a relapse of leukemia, and a third from intestinal bleeding after gallbladder removal, he says.
Byetta and Pancreatitis
The association between Byetta and pancreatitis has been known. "Since 2006, the U.S. prescribing information for Byetta has included information about pancreatitis," says Donald Therasse, MD, Lilly's vice president of global patient safety, who also spoke at the conference. "In 2007, after discussions with the FDA, Amylin and Lilly amended the prescribing information to include pancreatitis as a precaution." A letter alerting doctors was sent in October 2007.
Therasse says that the letter explained that while a cause and effect has not been established between Byetta use and pancreatitis, "an association is suspected."
Even so, he says, "based on our evaluation we believe Byetta continues to have a positive benefit-risk profile for patients with type 2 diabetes."
Patients with type 2 diabetes have nearly three times the risk of developing pancreatitis than the general population, company officials say, citing a study presented at a 2008 meeting of the international society for pharmacoepidemiology.
"For every 3,000 patients who have taken Byetta for a year, one would have reported a case of pancreatitis," Kolterman says, citing statistical risk from information gathered since the Byetta launch. "Most pancreatitis cases resolve with supportive treatment and stopping the suspected medication, including Byetta."
Life-threatening pancreatitis has been rare in Byetta users -- less than 1 in 10,000 case reports, Kolterman says. Since June 2005, about 1 million patients have used the drug, Kolterman estimates.
Officials from both pharmaceutical companies say they are in ongoing discussions with the FDA about possible changes to the drug labeling and wording.
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