- TUESDAY, Aug. 26 (HealthDay News) — The makers of the type 2
diabetes drug Byetta reported Tuesday the deaths of four more people who'd
been taking the medication.

The announcement by Eli Lilly and Amylin Pharmaceuticals Inc. came a
week after the U.S. Food and Drug Administration said that two Byetta
users had died of acute pancreatitis, a condition that can cause nausea,
vomiting and abdominal pain.

Lilly's medical director, James Malone, said Tuesday that the FDA was
aware of the four additional deaths last week, but did not make them
public because they involved a milder form of pancreatitis, the
Associated Press reported.

“They [the FDA] were concentrating on the more severe forms of the
condition, but we felt it was important to get this information out
there,” Malone told the news service.

All four patients had complicating medical conditions in addition to
type 2 diabetes; those conditions ranged from leukemia to gallstones,
which were likely the primary cause of death, Malone told the
AP.

Lilly could not rule out a link between the drug and the pancreas
problems, Malone said, but he noted that there have been reports of
similar problems with rival medications.

“While a definite causal relationship between Byetta and pancreatitis
has not been proved, to better understand the suspected relationship
Amylin and Lilly continue to pursue a comprehensive drug-safety program
that includes extensive internal and external review of individual cases,
and clinical and epidemiologic studies,” said a joint statement from the
companies, MarketWatch reported.

On Aug. 18, the FDA said two deaths had resulted from six recent cases
of pancreatitis among Byetta users. The agency said at the time it was
working on stronger labeling for the injected drug, which has been used by
more than 700,000 people since being approved in June 2005.

Last October, the FDA said there had been 30 reports of pancreatitis
among Byetta users. In that announcement, the FDA warned that people
should stop taking the drug if they developed symptoms of acute
pancreatitis, including nausea and abdominal pain.

More information

To learn more, visit the FDA.