Life-threatening haemorrhage secondary to nicorandil-induced severe peri-anal ulceration

Abstract

Nicorandil-induced ulceration is rare but has been reported at multiple sites throughout the gastrointestinal tract. We report a life-threatening complication of such ulceration -catastrophic per-rectal haemorrhage requiring emergency surgery with no prior symptoms. Whilst nicorandil should be considered in cases of chronic peri-anal and peristomal ulceration which fail to respond to conventional treatments, this case highlights its importance in the setting of acute surgical presentations.

Nicorandil‐induced ulcerations: a 10‐year observational study of all cases spontaneously reported to the French pharmacovigilance network

“…This 10‐year survey of 148 French cases of NIU is the first available survey based on spontaneous pharmacovigilance reports of both cutaneous and mucosal lesions induced by nicorandil. During this same period, 199 other cases were reported worldwide in 61 published articles: 173 cases of mucosal lesions, 21 cases of cutaneous lesions and 5 cases of mucosal and cutaneous lesions (Table ) .…”

Painful perianal ulcers with nicorandil

“…It is licensed in Europe (Austria, Denmark, France, Ireland, the Netherlands, Portugal, UK) and elsewhere for this indication. It is not approved for marketing in the US 12345678…”

“…Nicorandil, a drug occasionally used to treat symptoms of angina, can cause a rare but serious adverse reaction of painful, non-healing ulcers that affect the skin and mucosa 1. Failure to recognise this adverse drug reaction can result in serious harm to some patients 2345. The danger is increased because nicorandil treatment is usually initiated by cardiologists, but this rare adverse reaction usually presents to others, including general practitioners, surgeons, dentists, ophthalmologists, and dermatologists.…”

Nicorandil and Its Associated Gastrointestinal Side Effects

“…Occasionally the ulcers may progress to fistulas . Rarely‐life‐threatening perianal hemorrhage may occur . In this scenario emergency surgery is usually required.…”