The manufacturer of nicorandil (Ikorel®) has written to healthcare professionals advising of new restrictions to the licensed indication and additional contraindications and warnings.
Nicorandil is now recommended for the treatment of stable angina in patients whose angina is inadequately controlled by first line treatments or who have a contraindication or intolerance to first line treatments. First line treatments include beta blockers and calcium channel blockers.
It is also noted that nicorandil can cause serious skin, mucosal and eye ulceration that persists unless treatment is stopped. Treatment must be stopped if any ulceration develops and cardiologist advice sought if angina symptoms worsen.
Patients with diverticular disease may be at increased risk of fistula formation or bowel perforation. Patients taking aspirin, NSAIDs or corticosteroids are at increased risk of gastrointestinal ulceration.
Nicorandil is now contraindicated in hypovolaemia, acute pulmonary oedema and in combination with guanylate cyclase stimulators. It should be used cautiously in combination with medicines that increase potassium levels, especially in patients with moderate to severe renal impairment.
Action: Clinicians should be aware of these new restrictions and remain vigilant for ulceration in patients taking nicorandil.