Nicorandil

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Fistula, bowel perforation and ulceration: 21 case reports Fifteen women and six men aged 58–92 years developed fistulas, bowel perforation and parastomal and/or perianal ulceration during treatment with nicorandil [indications, routes and durations of treatment to reactions onset not stated]. All patients were receiving nicorandil at a daily dose of at least 40mg. Twelve patients had undergone colostomy (10) or ileostomy (2) for diverticular disease. Eighteen patients presented with parastomal ulcers and six patients had perianal ulcers. Histology of the ulcers showed nonspecific chronic inflammation. Three patients also developed skin fold ulcers, and one patient had oral ulcers. Bowel perforation was seen in ten patients, and 14 patients developed a colovesical (3), rectovaginal (2), colovaginal (3), colorectal (2) or colocolonic (1) fistula, or fistula in ano (3). Nicorandil was discontinued in all patients. In 18 patients, the ulcers resolved over the following 2–6 months. One patient with a perianal ulcer did not improve, and underwent a plastic surgical repair. One patient died from heart disease before a benefit was seen, and another patient died of ileal perforation. Author comment: "[N]icorandil would appear to be strongly linked with perforating diverticular disease and fistula formation. In those with no history of diverticular disease there is still an association with perianal and parastomal ulceration." Smith VM, et al. Nicorandil: Do the dermatological and gastrointestinal risks outweigh the benefits?. British Journal of Dermatology 167: 1048-1052, No. 5, Nov 2012. Available from: URL: http://dx.doi.org/10.1111/ 803081755 j.1365-2133.2012.11185.x - United Kingdom

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Reactions 12 Jan 2013 No. 1434