1999
DOI: 10.1002/(sici)1099-1557(199910/11)8:6<377::aid-pds448>3.3.co;2-3
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Pathogenesis of fibrosing colonopathy: the role of methacrylic acid copolymer

Abstract: Fibrosing colonopathy is a serious bowel disorder which was ®rst seen in 1991 in patients with cystic ®brosis treated with high doses of pancreatic enzyme supplements. Epidemiological evidence from two case±control studies, temporal data and direct experimental evidence support the conclusion that there is a causal relationship between the disease and intake of high doses of the excipient, methacrylic acid copolymer, which is used to coat certain brands of pancreatic enzyme. A high intake of lipase, the active… Show more

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Cited by 3 publications
(3 citation statements)
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“…[49][50][51][52] All were taking Nutrizym GR, the only standard-strength product available in the UK that contains the copolymer Eudragit L30 D55. Despite the rarity of the complication, the occurrence and severity of the condition had a major influence on attitudes to pancreatic enzyme treatment.…”
Section: Choice Of Pancreatic Enzyme Preparationmentioning
confidence: 99%
“…[49][50][51][52] All were taking Nutrizym GR, the only standard-strength product available in the UK that contains the copolymer Eudragit L30 D55. Despite the rarity of the complication, the occurrence and severity of the condition had a major influence on attitudes to pancreatic enzyme treatment.…”
Section: Choice Of Pancreatic Enzyme Preparationmentioning
confidence: 99%
“…Worldwide to date there have been 85 reported cases of fibrosing colonopathy, including 18 in the United Kingdom (Bakowski M, personal communication). There has been debate over the role of high strength enzyme preparations or the use of high doses of enzymes in the aetiology of this condition, but it now seems likely that a methacrylic acid co-polymer (Eudragit) in the enteric coating of some preparations is the culprit 29. The risk of fibrosing colonopathy in patients receiving non-Eudragit-containing products, even at higher doses, appears extremely small.…”
Section: Nutritionmentioning
confidence: 99%
“…118 Recent studies have demonstrated that intake of high doses of methacrylic copolymer used as acid resistant coating in PES rather than the lipase itself may be the cause of fibrosing colonopathy. [119][120][121] This condition has also been reported in patients who have never received PES, but rather a different drug coated with methacrylic copolymer. 122 Pancreatin extracts are also prone to form insoluble complexes with folic acid, with the result that folic acid deficiency can develop in patients receiving PES.…”
Section: Adverse Effectsmentioning
confidence: 77%