China
Africa
Explore chapters and articles related to this topic
Respiratory, endocrine, cardiac, and renal topics
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Pancreatic enzyme supplements were believed to have no serious adverse effects until reports of colonic strictures first appeared in the early nineties [9]. This was a new condition in CF patients, with characteristic histological findings and was termed “fibrosing colonopathy.” A subsequent case-control study showed a dose dependent association between the risk of fibrosing colonopathy and the use of high strength formulations of pancreatic enzyme supplements [10]. The authors speculated that undissolved microspheres or mintablets might pass through the ileocaecal valve into the colon where lipase, protease and amylase might be released in high concentrations. There might also be a toxic effect on the colon of the inert components of the microspheres or minotablets. The UK Committee on Safety of Medicines subsequently issued a warning that enzyme doses should not exceed 10 000 units of lipase/kg/day.
Adverse effects of drugs on the gastrointestinal tract
Published in Michael JG Farthing, Anne B Ballinger, Drug Therapy for Gastrointestinal and Liver Diseases, 2019
Initial case reports suggesting that use of high-dose pancreatic enzyme supplements could cause a fibrosing colonopathy in patients with cystic fibrosis of the pancreas were followed by descriptions of case series in the UK and elsewhere. Risk does not appear uniform. A UK national case-control study compared 14 cases (all but four were notified previously to the UK Committee on Safety of Medicines) occurring in 7600 patients with cystic fibrosis and matched controls (four per case). Cases had taken, on average, twice as much daily treatment as controls. Risks appeared greater in boys, in those with more severe cystic fibrosis and in those taking laxatives concomitantly. Nutrixyn 22 and pancrease HL were associated with risk whereas Creon 25000 was not. Creon 25000 is released by a different mechanism, and lacks the methyl methacrylate coating of the other preparations. Nutrizym GR, a standard dose supplement, has also been associated with the development of colonopathy. Following these reports, the Committee on Safety of Medicines has recommended that pancrease HL, Nutrizym 22, and Panzytrat 25000, which have similar release mechanisms, should no longer be used, and doses of any supplements should be limited to 10 000 units of lipase/kg/day.6 Subsequently, case reports have ceased.
Diagnosis and management of pancreatic exocrine insufficiency (PEI) in primary care: consensus guidance of a Canadian expert panel
Published in Current Medical Research and Opinion, 2018
P. Durie, J.-D. Baillargeon, S. Bouchard, F. Donnellan, S. Zepeda-Gomez, C. Teshima
The overall safety profile of pancreatic enzymes is similar across all formulations36,41–43. The most common adverse effects are gastrointestinal in nature (e.g. abdominal pain, abdominal distension, diarrhea, constipation, vomiting, nausea) and generally mild to moderate in severity; some may be symptoms of the underlying disorder, rather than a treatment effect. Pancreatic enzymes come with a warning for fibrosing colonopathy, a rare but serious adverse drug reaction whose risk appears to be directly related to dose, as documented in CF patients40,44. Allergy and hypersensitivity reactions, mainly skin rash, have been reported but occur rarely. More commonly, infants and others may experience perianal irritation, especially early in treatment.