More recent research has shown that drugs containing omega-3 polyunsaturated fatty acids, used to lower blood cholesterol and triglycerides, carry an increased risk of atrial fibrillation, a heart rhythm disorder that can weaken the heart and lead to heart failure. .
The warning comes from the National Agency of Medicines and Medical Devices in Romania (ANMDMR), which states that the greatest risk was found to be “at a drug dose of 4 g/day”. In addition to medicines, there are also many food supplements with omega-3 fatty acids on the Romanian market, which people consume like candy.
“In agreement with the European Medicines Agency (EMA) and the Romanian National Agency for Medicines and Medical Devices (ANMDMR), the holders of marketing authorizations for medicines containing ethyl esters of omega-3 acid wish to inform you about to the following: Several systematic reviews and meta-analyses of randomized controlled trials have shown a dose-dependent increased risk of atrial fibrillation in patients with pre-existing cardiovascular disease or cardiovascular risk factors treated with medicinal products containing ethyl esters of fatty acids omega-3, compared to placebo (inactive preparation, which has no effect – no)”, ANMDMR sent yesterday, in a communication addressed to health professionals.
Considered “good fats”
There are three types of fatty acids: saturated, monounsaturated and polyunsaturated. Omega-3 acids are also part of the last category – i.e. that of polyunsaturated fatty acids (PUFA), which are known to be beneficial fatty substances, which have an essential role in the functioning of the cardiovascular system and the brain at optimal parameters. The ethyl esters of omega-3 acids are EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) – frequently found in fish oil and major components of the active substance in the two drugs (Omacor and Tevocor) referred to by representatives of the Medicines Agency.
“Medications containing omega-3 acid ethyl esters are indicated to reduce triglyceride levels (hypertriglyceridemia) when dietary measures alone are insufficient to produce an adequate response,” they explain.
The evaluation of these medicines with omega-3 polyunsaturated fatty acids was carried out by the EMA Safety Committee (PRAC). According to the ANMDMR, they analyzed “data from several systematic reviews and meta-analyses of large randomized controlled trials (RCTs) that enrolled more than 80,000 patients, mostly with cardiovascular disease or cardiovascular risk factors, and investigated cardiovascular effects of omega-3 fatty acid treatment compared with placebo”.
“Data from these studies showed a dose-dependent increased risk of atrial fibrillation in patients with pre-existing cardiovascular disease or cardiovascular risk factors who were treated with drugs containing omega-3 ethyl esters compared with those treated with placebo. The observed risk proved to be the highest at the drug dose of 4 g/day”, the information states.
Given that, for both drugs, one capsule has 1,000 mg, it follows that the dose referred to by ANMDMR representatives is 4 capsules per day.
Atrial fibrillation, listed on the leaflet as a common adverse reaction
Following the assessment of this research, the EMA recommended that the product information of these medicines should be updated to include the data on the risk of atrial fibrillation obtained from these studies and also to include atrial fibrillation as a common adverse reaction.
At the same time, experts recommend stopping treatment in patients who develop atrial fibrillation, one of the most common and also the most dangerous heart rhythm disorders.
“Healthcare professionals should advise patients to seek medical attention if they develop symptoms of atrial fibrillation. If patients develop atrial fibrillation, the treatment with these drugs must be stopped permanently”, ANMDMR warns.
At the same time, the Agency appeals to medical staff, but also to patients to report adverse reactions: “It is important to report any suspected adverse reaction, associated with the administration of drugs containing ethyl esters of omega-3 acid, to the National Agency of Medicines and Medical Devices in Romania”, using the reporting forms available on the website www.anm.ro, in the section Medicines for human use/Report an adverse reaction.
Omega-3 supplements, consumed in large quantities
Ethyl esters of the omega-3 acids EPA and DHA are not only part of the medicines specified by the Medicines Agency, which can be bought in pharmacies in Romania on the basis of medical prescription, but also in dozens, maybe even hundreds of food supplements.
These, however, do not fall under the jurisdiction of the Medicines Agency and are generally not subject to any control by an official state authority. Moreover, Romanians can buy them over the counter, without a “prescription”, not only from pharmacies, but also from supermarket shelves.
Many people consume these omega-3 supplements in large quantities, preventively or to reduce their elevated cholesterol, being considered “beneficial” and without adverse effects.
Moreover, on the websites of online pharmacies there are also references to the “multitude of beneficial effects” that these supplements have on the body: “contributes to the normal function of the heart”, “beneficial in atherosclerosis”, “normalizes blood pressure”, ” for a healthy diet” etc.
Why is atrial fibrillation dangerous?
One of the most common heart rhythm disorders, atrial fibrillation is dangerous because, if not treated properly, it can weaken the heart and lead to heart failure or stroke.
“The main complication of atrial fibrillation is stroke. In atrial fibrillation, chaotic contractions of the atria can cause blood to stagnate in the atria and form clots. If such a clot leaves the heart it can end up circulating in an artery that feeds the brain. There it could block the flow of blood, causing a stroke”, according to cardioportal.ro, the website of the Romanian Cardiology Society.
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2023-11-09 13:04:15
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