Dangerous Heart Drug: Nicorandil Linked to Organ Damage & Calls for Withdrawal

The heart medication nicorandil, used to treat angina, is facing renewed scrutiny after the French medical journal Prescrire called for its definitive withdrawal from the market. This call follows decades of alerts regarding serious, and sometimes fatal, side effects, including organ perforation. The concerns center on a risk-benefit profile that experts now deem unfavorable, particularly given the drug’s limited efficacy compared to other angina treatments.

A History of Warnings

Nicorandil works as a vasodilator, widening blood vessels to improve blood flow to the heart. While it can provide relief for stable angina – chest pain experienced during exertion or stress – it’s generally reserved for patients who haven’t responded to first-line treatments like beta-blockers or calcium antagonists. Despite this positioning as a “last resort,” approximately 71,000 patients in France were using nicorandil in 2024, with nearly a million boxes reimbursed by the national health insurance system, according to reports from Le Tribunal du Net.

However, the drug’s use has been shadowed by safety concerns for years. The French National Agency for Medicines and Health Products Safety (ANSM) issued warnings in 2012 and 2015 regarding adverse effects. These alerts were renewed in November 2025 due to the risk of severe ulcerations. Now, Prescrire argues that these risks, coupled with the drug’s questionable effectiveness in preventing angina attacks, warrant its complete removal from the market. The journal addressed a formal letter to both the ANSM and the High Authority of Health (HAS) on March 9, 2026, outlining their concerns.

The Severity of Ulcerations and Perforations

The most significant danger associated with nicorandil is its potential to cause chronic and painful ulcerations. These aren’t limited to the digestive system; they can affect the skin, particularly on the lower limbs, mucous membranes (mouth, intestines, anus, vagina), and even the cornea of the eye. A French study identified 62 cases of these ulcerations between 2017 and 2024, but experts believe this number is likely an underestimate due to underreporting. Trumedical reports that diagnosis is often delayed, with the link to nicorandil frequently overlooked for months.

Recent reports, including those from Le Figaro Santé, indicate that some patients have died as a result of organ perforation caused by these ulcerations. This underscores the potentially life-threatening nature of the drug’s side effects.

Understanding the Benefit-Risk Balance

The core of Prescrire’s argument lies in the unfavorable benefit-risk balance. While nicorandil can alleviate angina symptoms, its effectiveness in preventing more serious cardiac events hasn’t been definitively demonstrated. The severity of the potential side effects – particularly the ulcerations and risk of perforation – raises serious questions about whether the drug’s benefits outweigh its risks, especially when alternative treatments are available. The journal contends that the drug is “more dangerous than useful.”

What Does This Mean for Patients?

Individuals currently taking nicorandil should not stop their medication abruptly. Any changes to treatment plans should be discussed with a qualified healthcare professional. Doctors may consider transitioning patients to alternative angina medications, carefully monitoring for any potential withdrawal effects or changes in symptom control. It’s crucial to report any new or worsening symptoms, such as skin lesions, mouth sores, or abdominal pain, to a physician immediately.

The situation highlights the importance of ongoing drug safety surveillance and the demand for healthcare professionals to be aware of the potential risks associated with all medications. Patients should also be proactive in discussing their medical history and any concerns they have with their doctors.

The Regulatory Process and Next Steps

Following Prescrire’s letter, the ANSM and HAS will likely review the available evidence regarding nicorandil’s safety and efficacy. This review process may involve consulting with medical experts, analyzing data from clinical trials and post-market surveillance, and considering the perspectives of patient advocacy groups. The agencies could then take several actions, ranging from issuing updated warnings and prescribing guidelines to restricting the drug’s use or, as Prescrire recommends, withdrawing it from the market entirely.

The outcome of this review will likely have implications for angina treatment guidelines in France and potentially influence prescribing practices in other countries. Continued monitoring of nicorandil-related adverse events will be essential, regardless of the regulatory decisions made. MSN France notes that despite previous alerts, the medication remains 65% reimbursed by the French social security system, a point that may also come under scrutiny during the review process.