High-lipase pancreatins and colonic strictures

There have been cases of development of fibrotic strictures of the large bowel occurring in children aged between 3 and 13 years with cystic fibrosis who had been taking capsule preparations of pancreatin containing high levels of lipase and other enzymes for several months.

The CSM recommended:

• that pancreas HL, nutrizym 22 and panzytrat 25000 (now discontinued) should not be used in the management of children under 15 years of age with cystic fibrosis
• in patients with cystic fibrosis, the total dose of pancreatic enzyme supplements should not generally exceed 10,000 units of lipase per kg bodyweight daily. There was no association found with Creon 25000
• if a patient treated with any pancreatin preparation develops new abdominal symptoms (or any change in existing abdominal symptoms) then the patient requires review to exclude the possibility of colonic damage
• possible risk factors include more severe cystic fibrosis, gender (boys greater risk than girls), and the concomitant use of laxatives
• the peak age range for developing fibrosing colonopathy is between 2 and 8 years

Reference:

• (1) Letter from the Committee on Safety of Medicines. December 21st 1993.
• (2) BNF 1.9.3