According to a Reuters report, the US FDA has requested additional safety studies to ensure the benefits of exenatide (Byetta®) outweigh the risk of inflammation of the pancreas and acute renal failure.

A letter posted on the Agency’s website notes that it has ‘determined that post-marketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms’.  Please see the link below for details.