Anal ulceration associated with Nicorandil: case series and review of the literature.

Use of Nicorandil in the treatment of ischaemic heart disease has been associated with oral, ileal and more recently anal ulceration. We report a series of six cases of peri-anal ulceration in patients on nicorandil therapy, their response to withdrawal of the drug and review the literature. Systematic case note review of all patients with anal ulceration presenting to a single colorectal unit. Including detailed medical and drug history, morphological and histological appearances of the peri-anal ulcer after biopsy. Nicorandil therapy stopped in conjunction with physician and the progress of the ulcer monitored. Photographs taken before and after cessation of Nicorandil after informed consent. A literature search on Nicorandil combined with the key words: anal, peri-anal, ulceration and adverse drug effects was performed using the Cochrane Library Medline (January 1966 to June 2005) and Embase (January 1974 to June, 2005). Six patients were identified from our hospital records. Histological examination of all ulcers revealed nonspecific chronic inflammation. Five patients demonstrated healing of ulceration within six weeks of withdrawal of Nicorandil, the remaining patient had circumferential involvement of the anal canal and has not improved at 3-month review. One patient was recommenced on Nicorandil after healing due to refractory angina and ulceration recurred. We believe ulceration due to Nicorandil remains widely under diagnosed and the mechanism of ulceration is unclear. Despite diversion colostomy one of our patients continued with peri-anal ulceration, which may suggest a systemic mechanism rather than local irritation. Biopsy of these lesions is essential to exclude neoplastic process and inflammatory bowel disease.