Decision Report 201601684

Summary

Mr C complained that his wife (Mrs A) underwent a number of surgical procedures for an anal fistula (an abnormal opening in the anus). He said that the procedures may have been unnecessary had staff at Inverclyde Royal Hospital identified that her high dose of Nicorandil (a medication used to treat angina) may have been the likely cause.

In responding to the complaint, the board acknowledged the possibility of a link between the Nicorandil and anal fistula, but said the only way to check was by stopping the medication to see if there were any improvements.

We took independent medical advice from a consultant colorectal surgeon. We found that although Nicorandil is known to cause mouth and rectal ulcerations when prescribed in higher doses, its association with anal fistula is much less clear. Therefore, given Mrs A did not present with ulceration, we considered it was reasonable that the surgeons involved in her care did not make the association between the anal fistula and Nicorandil. We concluded it was only with hindsight that the Nicorandil should have been stopped sooner.