Exenatide (Byetta)
admin October 17th, 2007
The FDA have issued a warning about pancreatitis associated with exenatide. In a review of 30 spontaneous reports of pancreatitis associated with exenatide, 27 had risks factors associated with pancreatitis, 22 patients improved on withdrawal of the drug, and a further 5 cases seemed to provoked by a change to a higher dosage. The FDA advise:
Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.
Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.
Suspected adverse drug reactions associated with exenatide can be reported in the UK to the Yellow Card scheme. As exenatide is a black triangle drug, any reactipn, no matter how trivial, should be reported.