The Ritmodan Shortage: When Cardiomyopathy Patients Are Left Without Essential Care

A Cry of Alarm from the AICARM Association

edited by AICARM APS Editorial Staff

The shortage of essential drugs is no longer an episodic problem, but a systemic reality that severely affects the most vulnerable patients. The Italian Association for Cardiomyopathies (AICARM) is today at the forefront in denouncing a situation that goes beyond the pharmacological emergency: the prolonged unavailability of Rhythmodan (disopyramide), a key drug for the treatment of hypertrophic obstructive cardiomyopathy.

The AICARM Press Release: A Necessary Report

On June 25, 2025, the President of AICARM, Professor Franco Cecchi, released a statement that leaves no room for interpretation:

 

"The Italian Association for Cardiomyopathies (AICARM) expresses its strong concern about the continuing shortage of the drug Ritmodan, widely used by patients with success as a therapy for hypertrophic obstructive cardiomyopathy.

AICARM, founded in 2019 with the aim of contributing to improving the quality of life of patients and protecting their rights, cannot remain indifferent to the clear violation of a fundamental right, such as that of having access to the drugs necessary for the treatment of cardiomyopathies, as has already happened in recent years with Disopyramide and Nadolol, both marketed by CHEPLAPHARM AG, based in Germany.

 

The press release continues by highlighting how AICARM has contacted AIFA since the problem emerged, without however obtaining concrete solutions. The situation has reached critical levels, with the concrete risk of triggering speculative phenomena and hoarding that force patients into a real "drug hunt", often at exorbitant prices.

A Worrying Pattern: Not Just the Ritmodan

The Ritmodan shortage is not an isolated case in the recent history of AICARM. The association has already faced similar problems with other essential drugs such as Nadolol and Disopyramide itself, all marketed by the same German company CHEPLAPHARM AG. This pattern raises questions about the vulnerability of the pharmaceutical system when the production of life-saving drugs is concentrated in the hands of a single manufacturer.

 

As underlined in the press release: “For Nadolol, it was possible to overcome the deficiency also with galenic preparations, but Disopyramide does not appear to be available on the market.".
This difference in the availability of alternatives highlights how some patients find themselves in a situation of particular vulnerability.

The European Context: A Systemic Problem

The problem addressed by AICARM is part of a much broader picture involving the whole of Europe. The European Society of Cardiology has recently published a study highlighting how drug shortages represent an emerging challenge for healthcare systems, with substantial financial, logistical and ethical implications.
The European Medicines Agency responded to this emergency by creating a “Union List of Critical Medicinal Products”, updated in December 2024, which includes over 240 active substances considered essential. The inclusion criteria are based on the severity of the pathologies treated and the lack of easily replaceable alternatives in case of shortage – exactly the situation that patients with hypertrophic obstructive cardiomyopathy are experiencing with Ritmodan.

The Impact on Patients: Beyond Statistics

Behind every drug deficiency are human stories, people who depend on these drugs to maintain an acceptable quality of life. Hypertrophic obstructive cardiomyopathy is a condition that can cause debilitating symptoms such as dyspnea, chest pain and syncope. Ritmodan is often one of the few effective treatment options for these patients.
The “drug hunt” described by AICARM is not just a metaphor: it means patients who go from pharmacy to pharmacy, who desperately contact their doctors, who turn to alternative channels risking to run into counterfeit products or of dubious origin. It means families forced to sustain exorbitant costs for a drug that should be a guaranteed right.

AICARM Requests: Concrete and Systemic Actions

On June 25, 2025, the President of AICARM, Professor Franco Cecchi, released a statement that leaves no room for interpretation:

 

1. Immediate intervention by the institutions: “AICARM once again appeals to AIFA and also to all the competent institutions in the matter so that an adequate solution to the problem can be reached as quickly as possible.”

2. Systemic prevention: “In order to avoid further shortages, we then invite the competent bodies to organize not only the monitoring of the shortage, but a process of organizing the production and distribution of the missing drugs, which should not depend on a single, potentially monopolistic company.”

3. Legal protection: “Finally, AICARM will support, in a formal and substantial way, any initiatives by patients aimed at protecting their rights activated before the judicial authorities.”

 

Towards a Solution: The Technical Table and Beyond

Italian institutions are showing signs of awareness of the problem. AIFA has recently established a Technical Table for the Unavailability of Medicines, involving scientific societies in a collaborative approach to address pharmaceutical shortages. This is a step in the right direction, but it is necessary that the voice of patients, represented by associations such as AICARM, is listened to and integrated into these decision-making processes.

A Matter of Constitutional Rights

AICARM correctly frames the issue not only as a health problem, but as a violation of fundamental constitutional principles. The right to health, enshrined in Article 32 of the Italian Constitution, necessarily includes access to essential medicines. When this access is lacking for reasons beyond the patient's clinical condition, it is a violation that requires immediate and structural responses.

Conclusions: A Necessary Collective Commitment

AICARM's battle to guarantee access to Ritmodan represents much more than a single claim: it is the symbol of a broader struggle for a pharmaceutical system that puts patients' needs at the center rather than market logic.

The shortage of essential medicines cannot be accepted as a “side effect” of a modern health system. Instead, it requires:

• Diversification of production sources to avoid monopolistic dependencies

• Early warning systems to identify potential shortages before they occur

• Rapid compensation mechanisms when shortages occur

• Active involvement of patient associations in decision-making processes

AICARM's appeal is not only for patients with cardiomyopathy: it is for all those who believe that access to care is an inalienable right, not a privilege subject to market fluctuations. The voice of patients must be heard, and their requests transformed into concrete and immediate actions.

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