Diabetes News
FDA Plans Sterner Warning for Diabetes Drug Byetta After 2 Deaths
August 20th, 2008
Two more reports of haemorrhagic pancreatitis have once again raised concerns about the potential side effects of Byetta (exenatide), an injectable treatment for diabetes. First concerns were raised last October, when the FDA, the Food and Drug Administration in the USA, made public 30 reports of acute pancreatitis. Pancreatitis is common in diabetes, in those who consume excess alcohol and in those with excess fat in the blood. The companies that make Byetta (Amylin Pharmaceuticals and Eli Lilly) have stated that the proportion of complicated or fatal cases is “similar” to that observed in the general public but, given that exenatide (Byetta) is known to have powerful effects on the beta cells of the pancreas in stimulating insulin release, these new additional reports are being taken seriously and the label on Byetta is being amended.
Dr Ralph Abraham, at London Diabetes, comments “Byetta has made an enormous difference to my diabetes practice having weight loss and beta cell preservation properties that are important for nearly all patients with diabetes. The drug has been widely used in the last 2 years, particularly in the USA, and given its youth, we always had to be vigilant for new reports of side effects not mentioned in published clinical trials. At present, this is a rare but serious side effect and patients should be counselled to report any symptoms of sudden acute abdominal pain or fatty loose stools. There are no signs that the drug will be withdrawn yet. Patients at London Diabetes who are concerned about this report, should discuss the need for further treatment with their consultant”.
