French Heart Medication Faces Scrutiny: A Growing Trend of Drug Safety Concerns?
A leading French medical review, Prescrire, has called for the definitive withdrawal of nicorandil, a heart medication used to treat angina, citing serious and persistent side effects. This move, announced on March 9, 2026, highlights a growing trend of increased scrutiny regarding drug safety and the potential for medications to remain on the market despite known risks.
What is Nicorandil and Why the Concern?
Nicorandil is a vasodilator prescribed for angina – chest pain caused by reduced blood flow to the heart. It’s typically reserved for patients whose symptoms aren’t adequately controlled by first-line treatments like beta-blockers or calcium channel antagonists. However, despite being a treatment of “last resort,” approximately 71,000 patients in France were using nicorandil in 2024, with nearly one million boxes reimbursed by the national health insurance system.
The core issue lies in the drug’s association with severe and chronic ulcerations. A French study identified 62 cases of these ulcers between 2017 and 2024, affecting the skin (particularly on the lower limbs), mucous membranes (mouth, intestines, anus, vagina), and, in rare instances, the cornea of the eye. Experts believe this number is likely an underestimate, as many cases go unreported.
Delayed Diagnosis and Treatment Challenges
A significant problem is the delay in diagnosis. Ulcers linked to nicorandil can develop over months, often because healthcare providers don’t immediately consider the medication as a potential cause. Without stopping the drug, these ulcers are unlikely to heal, even with medical intervention.
What Should Patients Do?
Individuals taking nicorandil should be vigilant for symptoms such as red eyes, persistent sores (in the mouth, on the skin, or around the anus), blood in the stool, or rapid weight loss. If any of these appear, immediate medical attention is crucial. Dr. Gérald Kierzek advises against unilaterally stopping the medication without consulting a doctor, but emphasizes the importance of prompt evaluation and potential alternative treatments.
The Broader Implications: Increased Drug Safety Oversight
The Prescrire review’s call for withdrawal isn’t an isolated incident. It reflects a broader movement towards more rigorous drug safety evaluation and a willingness to question the continued apply of medications with significant risks, even if alternatives are available. The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued alerts regarding nicorandil since 2010, yet the drug remains reimbursed, a situation Prescrire deems “incomprehensible.”
This case raises questions about the balance between providing access to treatment and protecting patients from potentially devastating side effects. The availability of safer alternatives, such as nitrate derivatives, further strengthens the argument for reconsidering nicorandil’s place in clinical practice.
Alternatives to Nicorandil
Dr. Kierzek suggests discussing alternative treatments with a cardiologist, including nitrate derivatives with prolonged release, ivabradine, or ranolazine, as well as adjustments to first-line therapies. While generic versions of nicorandil remain available in France, their use is strictly regulated.
FAQ
Q: What is angina?
A: Angina is chest pain caused by reduced blood flow to the heart.
Q: What are the main side effects of nicorandil?
A: The most serious side effect is the development of chronic and painful ulcers, which can affect the skin and mucous membranes.
Q: Should I stop taking nicorandil if I experience side effects?
A: No, do not stop taking nicorandil without consulting your doctor. Seek immediate medical attention if you experience any concerning symptoms.
Q: Are there alternatives to nicorandil?
A: Yes, alternatives include nitrate derivatives, ivabradine, and ranolazine.
Q: What is the role of the ANSM?
A: The ANSM is the French National Agency for the Safety of Medicines and Health Products, responsible for monitoring and regulating drug safety.
Did you know? The number of reported nicorandil-related ulcerations may be significantly higher than official figures suggest, as many cases are not reported to health authorities.
Pro Tip: If you are taking nicorandil, maintain open communication with your cardiologist and promptly report any modern or worsening symptoms.
Have you or someone you know been affected by nicorandil? Share your experience in the comments below. For more information on heart health and medication safety, explore our other articles here and here. Subscribe to our newsletter for the latest updates on medical news and research.
