Gliptins and pancreatitis

Risk of pancreatitis with gliptins

• 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)).