Instructions for amiodarone drugs will indicate the risks of primary graft dysfunction after heart transplantation

This information, according to the letter, should be recorded in the special characteristics of the medicinal products or in the section "Special instructions". In addition, in the section "Side effects", the regulator considers it necessary to specify the possibility of primary dysfunction of the transplant after heart transplantation with the note "frequency unknown".

The “Special Warnings and Precautions” in the package inserts are required to include “the most important information for the patient about the risk of developing PDT,” including the fact that the doctor may change the treatment of patients on the waiting list for a heart transplant because “taking amiodarone before a heart transplant has been associated with an increased risk of a life-threatening complication” in which the transplanted organ “stops working normally during the first 24 hours after surgery.”

The Ministry of Health recommended adding to the list of the most severe adverse reactions requiring discontinuation of the drug the following: “primary graft dysfunction, in which the transplanted heart stops working properly” with a frequency gradation: “unknown – based on the available data, the frequency of occurrence cannot be determined.”

A letter from the end of January 2025 on the need to make changes was sent by the Scientific Center for Expertise of Medical Products of the Ministry of Health of Russia. Adjustments should be made in accordance with information on the experience of clinical use of amiodarone, as well as a letter from Roszdravnadzor from mid-December 2024.

Amiodarone is included in the list of vital and essential drugs and is used for the treatment and prevention of paroxysmal rhythm disorders - life-threatening ventricular arrhythmias, prevention of ventricular fibrillation, atrial and ventricular extrasystole, arrhythmia against the background of coronary insufficiency or chronic heart failure and other conditions. In Russia, registration certificates for drugs with this active substance have been issued to such companies as Atoll LLC, Novosibkhimpharm JSC, Ellara LLC and others.

In January 2025, the Department for Regulation of Medicines and Medical Devices sent an information letter to manufacturers of drugs containing azithromycin as the active ingredient. Among other things, the document recommended amending the instructions for such drugs, indicating the risk of sudden cardiovascular death in the "side effects" section.