Cardiac Access: Missing arrhythmia drug amiodarone will appear in August
The popular arrhythmia drug amiodarone (international nonproprietary name, INN), which disappeared from Russian pharmacies back in March 2025, should become available again in late July — early August, Izvestia found out. Earlier, the regional authorities, in particular the St. Petersburg Health committee, promised that the medicine would appear in May, but this did not happen. Currently, 18 contracts have already been signed with government agencies, which means that supplies will resume within a couple of months. The situation is similar with pharmacies, where the drug is expected in August. The information about what could have caused the supply disruptions is in the Izvestia article.
Why is amiodarone unavailable?
Pharmacological networks will receive the arrhythmia drug amiodarone after July 31, 2025, sources close to distributors told Izvestia. Currently, pharmacies in at least 51 regions do not have medicines with this active ingredient, Izvestia found out by analyzing specialized aggregators. Heart patients have been complaining about their absence since the beginning of spring.
In February 2025, the Department of Regulation and Circulation of Medicines and Medical Devices of the Ministry of Health issued an information letter for manufacturers. It recommended making changes to the instructions for use for amiodarone. The reason is the identification of a side effect: as it turned out, the use of the drug before heart transplantation increases the risk of transplant rejection.
According to the state register of medicines, in Russia the drug is produced by the companies Organica, Pharmasynthesis, Velpharm, Ozon Pharmaceuticals, Promomed, Abba Rus, Ellara and B-Pharm. In case of any changes in the composition, packaging and instructions, the medicine must be re-registered. Organica reissued its registration certificate on March 4, 2025, Velpharm on April 10, and Pharmasynthesis on April 11.
The re-registration process takes two to three months on average, Nikolai Bespalov, Director of Development at RNC Pharma, an analytical company, recalled.
"Sometimes the procedure may take longer, depending on how well the manufacturer has prepared the documents, what changes are being discussed and how quickly the Ministry of Health approves them," he explained.
The Ministry of Health confirmed to Izvestia that more than ten medicines with INN amiodarone have been registered in Russia.
"A number of companies have implemented changes to the instructions," the agency said. "The procedure for making changes to the registration dossier of a registered medicinal product takes the time prescribed by law, on average 60 days."
The Ministry noted that this procedure does not suspend the permission for the production, release and sale of an already registered medicinal product.
In addition, the Ministry of Health received applications for the re-registration of marginal selling prices from eight manufacturers.
"The applications have been sent to the Federal Antimonopoly Service of Russia for economic analysis," the Ministry of Health said. "The maximum deadline for reviewing applications from the FAS of Russia is July 2, 2025."
Sometimes suppliers do not go to auctions not because of the lack of a drug, but because of the low initial price, Nikolai Bespalov explained.
In June, federal and regional medical institutions have already signed 18 contracts for the supply of amiodarone. But before that, several auctions were declared invalid — none of the suppliers applied to participate in them.
Thus, amiodarone will become available again around July-August, that is, a couple of months after the conclusion of contracts with government agencies and pharmacy distributors, Nikolai Bespalov noted.
The editorial board also sent a request to the manufacturers of the drug asking them to inform when the drugs will appear in pharmacies and hospitals.
In June 2025, about 150% of the average monthly demand for the drug was released, the Ministry of Health reported.
"And currently, suppliers are taking measures to deliver it to pharmacies as soon as possible," the ministry said.
Ozon Pharmaceuticals informed Izvestia that it continues to manufacture the drug amiodarone.
— We have already shipped more than 60 thousand packages of the drug, and production will continue in the planned volume. A stable release schedule has been formed for the coming months," the company stressed.
At the same time, supplies were expected in the regions as early as May 2025. As the St. Petersburg Health Committee reported to Izvestia on May 12, one of the key suppliers of the drug to the St. Petersburg retail pharmacy chain, JSC Borisovsky Plant of Medical Preparations (BZMP, Belarus), announced the cessation of production from September 2024. With reference to the company Organica, they reported that the start of deliveries is scheduled for mid-May.
Will amiodarone be enough for all patients
Previously, amiodarone was also supplied by foreign manufacturers, in particular, in Russia there was a cordarone drug from the French company Sanofi. Now its supplies have been stopped. In the first quarter of 2024, 358.4 thousand packages of the drug from Sanofi entered the market, and in the same period of this year — 45.5 thousand packages, said Nikolai Bespalov.
Compared to last year, Russian manufacturers have increased their production volumes. In particular, according to RNC Pharma, in the first quarter of 2025, Organica JSC brought 244.6 thousand packages to the market, and in the same period of 2024 — 195 thousand. Ellara produced 113.2 thousand against 34.3 thousand, Promomed — 98.2 thousand against 26 thousand, B-Pharm — 20.3 thousand versus 5.2 thousand .
At the same time, the drug began to be produced by companies that had not previously dealt with it. Thus, Ozon Pharmaceuticals supplied 70 thousand packages in early 2025, Velpharm — 35.5 thousand, Pharmasynthesis — 6.5 thousand.
Supplies from Abba Rus have fallen — 0 this year against 77.6 thousand packages last year. Only 39.8 thousand packages were received from the Belarusian BZMP, and in the past — 223.3 thousand.
But in general, according to Nikolai Bespalov, there is less amiodarone on the Russian market than last year, primarily due to the withdrawal of cordarone.
On June 19, 2025, the Ministry of Health held a meeting with manufacturers of amiodarone, representatives of the Ministry of Industry and Trade, Roszdravnadzor and the Federal Antimonopoly Service to discuss increasing the availability of this drug.
"According to its results, manufacturers have submitted production plans for 2025," the Ministry of Health said. "According to information from manufacturers, in the third quarter of 2025, it is planned to put into civil circulation in volumes exceeding the average demand."
What are the analogues of amiodarone?
Currently, doctors have a large range of antiarrhythmic drugs in addition to amiodarone, Philip Paleev, First Deputy Director General of the National Research Medical Center of Cardiology of the Russian Ministry of Health, reminded Izvestia.
— The attending physician, if necessary, will select the most effective one with the minimum number of possible side effects, — he said. — All antiarrhythmic drugs require careful monitoring by a doctor, so they should only be prescribed by a doctor and given by prescription.
He added that amiodarone has "the greatest number of non-cardiac side effects from the thyroid gland, lungs, liver, and eyes."
— For these reasons, it is a "reserve drug" for most forms of cardiac arrhythmias. In this regard, amiodarone is prescribed by doctors much less frequently," the expert said.
Nevertheless, drugs with amiodarone have a wide range of prescriptions, Victoria Shemenkova, a cardiologist and hospital head at the UNI Clinic Medical Center, reminded Izvestia. According to her, these include, for example, the treatment and prevention of ventricular tachycardia, ventricular fibrillation, various types of supraventricular arrhythmias and atrial fibrillation (atrial fibrillation).
The expert noted that amiodarone has no complete analogues, but there are indeed hundreds of drugs with antiarrhythmic properties on the market. She named propanorm, bisoprolol and flecainide among the most in demand. These drugs are now available in pharmacies, Izvestia has confirmed.
— The main thing is not to replace amiodarone yourself, Victoria Shemenkova warned. — When switching to another medication, you need to consult a cardiologist, undergo a series of examinations, and only after that the specialist will select another antiarrhythmic drug.
Therefore, the current situation with the lack of the drug in pharmacies cannot be called catastrophic, Victoria Shemenkova said.
Переведено сервисом «Яндекс Переводчик»
