How to replace this essential drug for some heart patients? The Medicines Agency responds

Who are flecainide medicines intended for?

Sustained-release flecainide medicines, used to improve symptoms of heart rhythm disorders. Concretely, this antiarrhythmic modifies the transmission of nerve impulses to the heart muscle and fights against anarchic contractions. It is also used in patients who have an implantable cardiac defibrillator to reduce electric shocks.

Why are these drugs in short supply?

These drugs are currently in short supply worldwide. Problems that the laboratories explain by difficulties in the supply of raw materials and packaging items. According to the ANSM, “A date for a return to normal supplies cannot yet be brought forward, although supplies are regularly made..

So that the patients concerned can at least receive appropriate treatment, the ANSM has drawn up recommendations for pharmacists and prescribing doctors, in consultation with the French Society of Cardiology and its rhythmology and cardiac stimulation group, the unions and representatives of pharmacists. , the College of General Medicine and patient associations, including the association of wearers of cardiac electrical devices (Apodec).

The objective is to facilitate the implementation of a replacement treatment adapted to each situation, either directly via the pharmacist, or following medical advice, if another molecule must be used as a replacement.

What are the different alternatives?

The pharmacist must inform the patient when a replacement is necessary and advise him to see his doctor in the event of the occurrence of an adverse effect or symptom that he deems unusual. He also writes the name of the medicine delivered on the prescription and informs the prescriber of this replacement.

Several solutions are considered depending on the availability of treatments:

First-line solution

If supplies are sufficient, replacement with another specialty flecainide sustained-release (PR), or immediate, should be preferred. For example: a 150 mg LP capsule can be replaced by a 50 mg LP capsule and a 100 mg LP capsule, to be taken once a day;

If prolonged-release forms are not available, the pharmacist may replace them with an immediate-release specialty, respecting the same prescribed daily dose, and indicating to the patient that the dose must be divided into 2 doses per day ( morning and evening). For example: 1 100 mg tablet to be taken morning and evening, instead of 1 200 mg LP capsule once a day.

2nd intention solution

If the replacement prolonged-release (LP) or immediate-release specialties are out of stock, extemporaneous preparations of an immediate-release form of flecainide can be produced with a raw material for pharmaceutical use. For example: Flecaine LP 150 mg 1 capsule per day = masterful preparation of Flecainide acetate 75mg 1 capsule in the morning and 1 capsule in the evening.

Last solution requiring a consultation with a cardiologist

As a last resort, flecainide can be replaced by a drug based on propafenone, after consultation with a cardiologist and on presentation of a prescription. This consultation is necessary in order to control the patient’s heart rate, due to the bradycardic properties of propafenone (slowing of the heart rate). In addition, this substitution requires close monitoring, in particular by electrocardiogram on D8/D10, in order to check the patient’s heart rate. The dosage must be defined by the doctor on a case-by-case basis.