Byetta Does Not Cause Pancreatitis

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Byetta Does Not Cause Pancreatitis

Review of the records of deaths from patients who died of pancreatitis seems to have no reason to believe that Byetta plays a role in their deaths.

Remember that the “FDA Amendments Act requires dissemination of safety data, including in cases where causality has not been definitely determined.”

These deaths were all in type 2 patients, a diabetes group that has three times more common incidence of diabetes when compared to the general population. One million patients have taken Byetta which gives a rate of 0.34 events per 1,000 patient years.

The causes of death were as follows.
• Morbid obesity with extensive gallstone disease.
• Patient had stopped taking Byetta some months before the pancreatitis.
• Two patients died of complications of gall bladder surgery.
• One died of recurrent leukemia 2.5 months after recovering from pancreatitis.

David Nathan, Chief of the Diabetes Unit at Massachusetts General Hospital sees any cause is “not clear.”

“I’ve had 550-plus patients on Byetta and not a hint of pancreatitis,” Joseph Prendergast, founder and medical director of the Endocrine Metabolic Medical Center, told BioCentury. “I would think that we must get the information on those people who died, all their previous history, how it was used, and what kind of physician was using it.”

He added: “I don’t consider it to be a problem, and I surely don’t consider it to be related to the drug.”

Kenneth Burman, chief of the endocrine section at Washington Hospital Center, Washington, DC also did not find a reason to attribute pancreatitis to Byetta. The other endocrinologists at his center have not hesitated to use Byetta as before.

BioCentury Vol 16, #39, Pg. A15-16