On 31 October, Aifa had warned of the quota and then of the shortage of the medicine due to “production problems” until 8 March 2024. In reality, patients are already forced to go abroad. Heart patients ask Aifa for urgent intervention
On the sites and social channels of patients with hereditary heart diseases, the tom-tam is incessant: Pharmacies are running out of nadolol suppliesa beta blocker initially registered for conditions such as angina and high blood pressure, which is a lifesaver in patients with hypertrophic cardiomyopathy and genetic diseases associated with the risk of sudden death, including long QT syndrome and catecholaminergic ventricular tachycardia characterized by a high risk of heart rhythm irregularities which can cause syncope (loss of consciousness) and sudden death due to cardiac arrest, especially during conditions of physical and emotional stress.
«We are overwhelmed with requests of information from patients who would like to know where and how to find nadolol” says Professor Silvia Priori, director of the Molecular Cardiology Operational Unit in the Experimental Medicine area, at the Scientific Institutes of Irccs Maugeri in Pavia.
«The vast majority of patients are very worried about the situation that has been created» echoes Simone Succi, 43 years old from Florence, suffering from catecholaminergic ventricular tachycardia, one of the founding members of theassociation «A family for the heart».
«We immediately took action to respond to the numerous patients who request information by email but above all by contacting the “Hearts in listening” telephone service – adds Professor Franco Cecchi, president of Aicarm Aps, an association of patients and doctors -. Pharmacies in Switzerland and Italy that are able to prepare the “galenic” product were contacted. Their list is regularly updated on the website aicarm.it. Obviously these preparations are much more expensive.” The association, concerned about the persistent shortage of nadolol, wrote to the Italian Medicines Agency, asking for urgent intervention to resolve the situation.
What do people suffering from these pathologies ask for? «We want to be sure that nadolol will be available again in March, p
because otherwise we run a really big risk», is the appeal launched by Simone Succi.
The causes: «production problems»
The reason? «Production problems (lack of the active ingredient)», as the Italian Medicines Agency explains in one informative note of 31 October agreed with the German company from which Italy is supplied and published on the Aifa website. Specifically: «In the hospital channel, the medicine is distributed in a manner limited until 01/01/2024; from 02/01/2024 to 08/03/2024 the medicine will presumably be totally lacking; retail channel: the medicine will be totally lacking presumably until 03/08/2024». AIFA specifies that the supply shortage is not related to any defect in the quality of the medicine or safety problems.
In short, we are once again faced with a problem of drug shortages. Which also concerns the mexiletine, an antiarrhythmic produced for patients with genetic diseases of the heart and skeletal muscle in this case by the Military Chemical Pharmaceutical Plant of Florence (Ministry of Defense). Unfortunately, however, for several months the Military Chemical and Pharmaceutical Plant has also stopped production.
In the case of Mexiletina, possible shortages were already announced as early as January 31, 2022 for “adjustments to production plants”. There was an adjustment, but production did not resume. Patients’ anxiety about shortages of medicines is exacerbated by the fact that it is not the first time that nadolol supplies have run out: it also happened in 2009 and in 2014 it was even withdrawn from the market and then returned after protests sparked by patients who without the life-saving drug they feel at risk of arrhythmic death
What is nadolol and for which pathologies is it used
«Nadolol is a beta blocker, that is, it belongs to a class of drugs that reduces the effect of adrenaline on the heart in the cardiological field and this is particularly useful in patients with serious ventricular arrhythmias that are triggered when the patient has high levels of adrenaline — explains Professor Priori who is also Professor of Cardiology – Department of Molecular Medicine at the University of Pavia -. High adrenaline levels they typically are consequence or physical activitytherefore sport, training, or emotional stress and as in the case of a fright or a sudden loud noise. We even have patients who suffer from long QT syndromea disease particularly susceptible to sudden noises, which can lead to cardiac arrest because the telephone rings in the night.”
«The other disease treated with nadolol is called catecholaminergic ventricular tachycardia, which patients call CPVT, the acronym of the name in English. Even in these patients the arrhythmias are triggered either by emotion or physical activity. Beta blockers actually include many different types of drugs. But thereand international guidelineswhich for us are those of the European Society of Cardiology of 2022, they say that, as the data shows, only non-selective beta blockers are the most suitable for the two pathologies. And these are only two: nadolol and propranolol”, adds the cardiologist.
Theoretically, therefore, would there be an alternative to nadolol? «Aifa says to use propranolol, but it’s not the same thing – clarifies Priori -. We have had patients whose therapy was switched from nadolol to propranolol, not now, who died after the switch.”
«In our experience at the Cardiomyopathy Center of Florence, and also at the Cardiomyopathy Center of the Auxologico S.Luca Institute, where we use it preferably in most patients with hypertrophic cardiomyopathy, the drug is fundamental, due to its potency and particular pharmacodynamic characteristics – adds Professor Cecchi -. Nadolol is a very potent and non-selective beta-blocking drug with a long half-life
that is, its effect lasts up to 24 hours and can be taken even once a day, in doses ranging from 40, but in some cases of obstructive hypertrophic cardiomyopathy they can be 160 up to 200 mg per day. The drug considered equivalent, propanolol, has different characteristics, is currently available on the market only at a dose of 40 mg, equivalent on average to 20 mg of nadolol and must be taken 2-3 times a day”.
Simone’s story
As Simone Succi explains «nadolol is the most effective drug that was discovered. I have tried many others and none of them work as effectively. I was even hospitalized for 10 days in the coronary unit to try another one, but it wasn’t good. Coupled with another drug I take, flecainide, nadolol ensures that CPVT no longer presents arrhythmias even when making a certain type of effort. So for me it is a life-saving drug.”
Simone, who has an 11-year-old son who also suffers from catecholaminergic ventricular tachycardia, started having the first episodes in 1988. «I was 8 years old and I fainted at school. At that time it was thought to be a manifestation linked to my development. They took me to Meyer hospital, but they found nothing.”
«After less than a year I had it a second episode at the seaside and from there I started all the possible checks, but in those years nothing was known about my pathology. Until in ’94, through my cardiologist in Florence, I met the Pavia center and Professor Priori and from there I began all my studies and I was taken into care by them. However, the genetic defect was found in 2001. I also have a defibrillator
which, together with the drugs, gives me protection in cases of cardiac arrest”, he says.
Hunt for supplies
After learning of the AIFA note, he, like all other people with the same pathology or with long QT syndrome they started thinking about how to stock up until at least March 8 next year, the date by which according to AIFA the production of the drug should be regularized. «In recent days I went to Switzerland, because you can still get nadolol there. Here in Italy the local health authorities are bending over backwards and they can’t find it either. They have to order it abroad. Even in France and Germany it is impossible to find it and it is also scarce in Switzerland. I have to take three a day and therefore a box, which contains 30 tablets, doesn’t even last me ten days. So far I have made do by asking some specialized pharmacies, in Florence and also outside the city, to prepare the galenic for me.”
«But in Italy it is increasingly difficult because the active ingredient is also starting to run out
. Some pharmacies have told us patients, but nothing is certain, that perhaps in January the active ingredient will be available again: however, not even pharmacists are sure when they will be able to start making galenic preparations again. Then I found a pharmacy in Switzerland that prepares them for me and other patients. But the costs are exorbitant: in Italy a pack of 30 tablets costs around 11-12 euros. In Switzerland, I paid 100 euros for 100 pills. And the same amount is spent on the galenic preparation, considering the shipping costs.”
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December 4, 2023 (modified December 4, 2023 | 5:38 pm)
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