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• W3140102224 abstract "Author's reply Sir—By selective quotation, Marie Bakowski misrepresents the entirely accurate assertion “that several reports now associate cases of fibrosing colonopathy with various pancreatin products including Creon 25000 and low strength formulations”. In question, is whether high doses of all enteric-coated pancreatic enzymes are associated with fibrosing colonopathy, or only those with an enteric coating of the methacrylate acid copolymer Eudragit L30D-55. Smyth and colleagues1Smyth RL van Velzen D Smyth AR Lloyd DA Heaf DP Strictures of ascending colon in cystic fibrosis and high strength pancreatic enzymes.Lancet. 1994; 343: 85-86Summary PubMed Scopus (257) Google Scholar originally reported the association between colonic strictures (now termed fibrosing colonopathy) and a high intake of the pancreatin products coated with Eudragit L30D-55 (Pancrease and Nutrizyme), but found no association for HP-55 phthalate enteric-coated pancreatin (Creon). Subsequently, Taylor2Taylor CJ Colonic strictures in cystic fibrosis.Lancet. 1994; 343: 615-616Abstract PubMed Scopus (34) Google Scholar reported a Creon-associated case and a large US study failed to support the distinction between different pancreatic enzymes (ie, did not exonerate Creon).3Freiman J FitzSimmons SC Colonic strictures in patients with cystic fibrosis: results of a survey of 114 cystic fibrosis care centres in the US.J Pediatr Gastroenterol Nutr. 1996; 22: 153-156Crossref PubMed Scopus (40) Google Scholar The Pharmacovigilance Unit of the UK Medicines Control Agency has now received seven reports of intestinal stricture associated with Creon products.* There are fewer reports for Creon products than for products coated with Eudragit and there are some reports that associate stricture lesions of the small intestine with the use of Creon products. Such lesions may not have been examined histologically, but in other patients, pancreatin-related small-intestinal submucosal fibrosis has been histologically confirmed. The exact site of pancreatin-induced intestinal toxicity may vary according to factors related to individual patients, or to the dissolution characteristics of the enteric coating. Although causality is not established by reports of adverse reactions, and they do not indicate the comparative incidence of fibrosing colonopathy for different products, these reports, in conjuction with other data, are sufficient to lead one to suspect that high doses of all enteric-coated pancreatin enzymes may have some potential to cause gastrointestinal toxicity. Significantly, five of the seven Creon reports were not confounded by any earlier or concomitant exposure to Pancrease or Nutrizyme products. By contrast, six of the ten Nutrizyme-associated reports and five of the 12 Pancrease-associated reports did have previous or concomitant exposure to Creon products. Moreover, for reasons unknown, more reports of gastrointestinal obstruction have been associated with Creon products than with other types of pancreatin. My hypothesis on the pathogenesis of fibrosing colonopathy is that the irritant enzymic effect of enteric-coated pancreatin is a key factor, not that the enzymes or the enteric coating is the sole cause. The Paracelcian quote “solely the dose distinguishes a remedy from a poison”, does not restrict “dose” to the active ingredient. Bakowski questions whether even low doses of pancreatin products marketed by companies other than her own are safe. This question is not really the issue, because fibrosing colonopathy has been associated only with pancreatin intakes in excess of those which were recommended or shown to be efficacious and safe. Her comment suggests either that she envisages a unique, but unexplained, dose-response relation, or that she has not yet accepted a 400-year-old principle of toxicology. When one component of a product, such as the enteric coating, alters or enhances the delivery of others, toxic effects cannot be assumed to be solely determined by a single component. This effect has previously been shown for intestinal ulceration induced by Osmosin (controlled-release indometacin) and intestinal perforation induced by enteric-coated potassium chloride. The most rational way to investigate the mechanism of toxicity or the pathogenesis of fibrosing colonopathy is by experimentation. The view that the only relevant experiment has already been done, eschews the opportunity to resolve clinical uncertainties caused by patients who switched between different pancreatin products and changed dose levels. Ideally, comparative oral toxicology studies should be undertaken with the two different types of enteric coating plus excipients and with the respective formulated pancreatin products, at the high-dose levels used clinically, for 6–12 months. Until such studies are done, the true role of enteric coatings in the development of fibrosing colonopathy is open to question. Pancreatic enzymes and fibrosing colonopathyIn the absence of any significant new evidence, it is surprising that C J Powell (March 13, p 911)1 seems to have changed his opinion since May, 1995, when, as a member of the UK's Committee on Safety of Medicines Working Party on Pancreatic Enzymes, he presumably supported the Working Party's conclusions that only certain brands of pancreatic enzymes (pancreatins) were associated with fibrosing colonopathy. Specifically, the Working Party concluded that cases had not to date been associated with the pancreatin product Creon 25000. Full-Text PDF Pancreatic enzymes and fibrosing colonopathyIn C J Powell's review of colonic toxicity from pancreatins,1 he advances the hypothesis that long-term exposure of the colon to high-strength pancreatins is the cause of fibrosing colonopathy. He also suggests that many patients have developed less severe colonic damage as indicated by ultrasound studies that show submucosal thickening.2 We do not agree with these suppositions and believe that high-strength (non-Eudragit-containing) pancreatin micropsheres do not have adverse effects on the colon. Full-Text PDF Pancreatic enzymes and fibrosing colonopathyC J Powell1 reports that the UK epidemiological study by Smyth and colleagues2 indicated “an odds ratio of greater than 8 for some pancreatic preparations”, but he fails to point out that, in the same study, the odds ratios for the pancreatin products Creon and Creon 25000 were 0·16 and 0·38, respectively. The US report by FitzSimmons and colleagues3 did not show any differences between specific products, partly because the case-control study was matched on centres, but also because of an inappropriate statistical interpretation of their analyses. Full-Text PDF Pancreatic enzymes and fibrosing colonopathyC J Powell1 addresses most features of fibrosing colonopathy. However, his reference to Ghanayem and colleagues' report2 on ethyl acrylate toxicity omits the relevant finding that rats, receiving 14 daily doses of 200 mg/kg ethyl acrylate by gavage, showed striking submucosal fibrosis in the forestomach characterised by mature collagen similar to that in fibrosing colonopathy. Full-Text PDF" @default.
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• W3140102224 title "Pancreatic enzymes and fibrosing colonopathy" @default.
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