The European Medicines Agency (EMA) and the Spanish Agency for Medicines and Healthcare Products (Aemps) have identified possible new adverse reactions to omega-3-based medicines. According to the EMA and Aemps, these drugs can increase the likelihood of developing atrial fibrillation in people with cardiovascular disease or with certain cardiovascular risk factors, such as a high body mass index, smoking or high blood pressure. The risk of developing these arrhythmias is greater with higher doses, especially the maximum dose of 4 grams per day.
Additionally, they note that this is a common adverse reaction, occurring in 1% to 10% of patients taking these drugs. This is in addition to the side effects already seen in its labeling, some of which are rare, such as gastroenteritis, dizziness, taste changes, and allergic reactions, while others are more common, such as indigestion and nausea.
What is ventricular fibrillation?
Atrial fibrillation is an abnormal rhythm in the upper chambers of the heart that causes the heart to beat very fast. It is not a fatal disease in itself, but its consequences can be: if the blood does not flow through the ventricles at the appropriate speed, it clots and forms clots, which then travel to other parts of the body (brain, lungs…). This can lead to conditions such as stroke or pulmonary embolism.
Atrial fibrillation arrhythmias may go unnoticed but sometimes cause symptoms such as palpitations, fatigue, shortness of breath, and dizziness. People taking omega-3 medications (especially at the highest doses) and experiencing any of these symptoms should see a doctor, according to advice from the Organization of Consumers and Users (OCU).
What omega-3 based medicines are sold in Spain?
There are currently four drugs produced from omega-3 on the market in Spain for the treatment of hypertriglyceridemia, all of which require a doctor’s prescription:
– Kern Pharma Omega 3 Acids 1,000 mg Softgel.
– Strides Omega 3 Acids 1,000 mg Softgels.
– Teva omega 3 acids 1,000 mg softgel.
-Omacor 1,000 mg softgel.
The recommended daily dose of these medications is two capsules per day, but if triglyceride levels are not controlled, they may be increased to 4 capsules, the maximum recommended dose.
What about omega-3 supplements?
These dietary supplements do not fall under the jurisdiction of the medicines regulator, so there is no evidence whether the EMA warning on omega-3 medicines also applies to these products. However, the OCU assures that “this may be the case”: “The fatty acids in omega-3 food supplements are often the same as those in medications. Generally speaking, however, they tend to be present in smaller amounts and the recommended daily dose is lower ,” he pointed out.