Byetta Deaths: And Now There Are Six…

Washington, DCJust days after the US Food and Drug Administration (FDA) announced two deaths linked to the diabetes drug Byetta, comes word that four more people have died in association with the use of the injectable drug.

This time it wasn't the FDA, but the manufacturers themselves coming forward. At a press conference August 26, representatives from Eli Lilly and Amylin Pharmaceuticals revealed that the four new deaths are in addition to the two deaths previously announced, but do not relate to the four individuals hospitalized previously with complications related to Byetta. Those people, presumably, are still in hospital and continue fighting for their lives.

Nonetheless, six people have died. Of the initial two deaths originally announced by the FDA, it was revealed that one person was morbidly obese at 400 pounds and was found to have extensive gallstones at autopsy. The second death was due to necrotizing pancreatitis, a horrific condition typified by inflammation and tissue death associated with the pancreas, the latter actually destroying itself.

As for the most recent deaths, one individual succumbed to complications from gallbladder removal, another from a relapse of leukemia, and a third from intestinal bleeding. Cause of the fourth death was not announced.

In all six deaths, the one commonality was the use of Byetta to control Type 2 diabetes.

Manufacturers Amylin Pharmaceuticals and Eli Lilly are quick to defend Byetta, in spite of these most recent deaths. Company officials maintain that one million people have used Byetta since it was released to market in 2005, and that for every 3000 patients who have taken Byetta for a year, one would have developed pancreatitis. Those suffering from acute pancreatitis, which is life threatening, account for less than one out of every 10,000 Byetta users, according to the manufacturers.

It was acknowledged that while a cause and effect has not yet been established linking Byetta to pancreatitis, "an association is suspected."

Byetta first went on the market in June of 2005. Within a year, the manufacturers were forced to update the product label with regard to pancreatitis. "Since 2006, the U.S. prescribing information for Byetta has included information about pancreatitis," said Dr. Donald Therasse, Eli Lilly's Vice President of Global Patient Safety, who spoke at the conference on Tuesday. "In 2007, after discussions with the FDA, Amylin and Lilly amended the prescribing information to include pancreatitis as a precaution."

The manufacturers go on to say that patients with Type 2 diabetes present nearly three times the risk of developing pancreatitis over the general population. Still, both Eli Lilly and Amylin acknowledge that they are in ongoing discussions with the FDA with regard to 'possible changes' to the drug labelling and wording.

Given Lilly and Amylin's acknowledgement of a 'suspected association' between Byetta and the onset of pancreatitis, it would be fair to suspect that the deaths of six people taking Byetta for their Type 2 diabetes were associated with the Byetta they were taking.

Still, these reported deaths are not enough to move the manufacturers away from their position with regard to the drug's benefits, or risks for pancreatitis—a risk that has been known since 2006.

Says Dr. Therasse, "based on our evaluation we believe Byetta continues to have a positive benefit-risk profile for patients."

Tell that to the families of the six who have died.