6 Deaths Reported From Diabetes Drug Byetta
Cause of Death Varies, but Patients Had Developed Pancreatitis
By
Kathleen Doheny
WebMD Health News
Reviewed By
Louise Chang, MD
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.
Additional reporting by Miranda Hitti.
SOURCES: Teleconference and audio conference, Aug. 26, 2008, co-hosted by Amylin
Pharmaceuticals, San Diego, and Eli Lilly & Company, Indianapolis. Orville Kolterman, MD, senior vice president of research and development,
Amylin Parmaceuticals. Donald Therasse, MD, vice president of global patient safety, Eli Lily &
Company. FDA: "Information for Health Care Professionals: Exenatide (marketed as
Byetta)." WebMD Health News: "FDA OKs Lizard Spit Drug for Diabetes." WebMD Health News: "Diabetes Drug Byetta: Pancreas Risk?" Byetta web site.
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