an increased risk of acute pancreatitis has been identified for all approved DPP-4 inhibitors
for most of the compounds this was detected in spontaneous post-marketing reports; for one of the newer compounds, linagliptin, a small increased number of cases compared with placebo was detected in clinical development. Consequently, pancreatitis is now included in the product information for all DPP-4 inhibitors as a possible adverse reaction
reporting rate of pancreatitis appears to be low (ranging between 1/1 000 and 1/100 patients receiving the drug) but the precise frequency is unknown as few cases have been reported in clinical trials
in most cases, pancreatitis resolved after discontinuation of treatment. The possible mechanism leading to acute pancreatitis is not clear
data from animal studies have been inconclusive or have not suggested a safety concern
also note that patients with diabetes are known to have a higher incidence of pancreatitis compared with non-diabetic patients
advice for healthcare professionals:
patients treated with DDP-4 inhibitors should be informed of the characteristic symptoms of acute pancreatitis - persistent, severe abdominal pain (sometimes radiating to the back) - and encouraged to tell their healthcare provider if they have such symptoms
if pancreatitis is suspected, the DPP-4 inhibitor and other potentially suspect medicines should be discontinued
report suspected adverse reactions through the Yellow Card Scheme - see www.yellowcard.gov.uk. When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, and treatment dates
Reference:
MRHA (September 2012). Drug and Safety Update (6; (2)).
Annotations allow you to add information to this page that would be handy to have on hand during a consultation. E.g. a website or number. This information will always show when you visit this page.