Omega-3 fatty acid “medicines” in Europe can no longer contain labels stating that they are effective in preventing cardiovascular events after an MI, states European Medicines Agency (EMA).
Omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack, concluded EMA, based on a review of data accumulated over the year. This means that these medicines would be no longer authorized for secondary prevention of CVD following myocardial infarction.
The review looked at results from the open-label GISSI Prevenzione study performed in 1999 which supported the initial authorization of these medicines, as well as retrospective cohort studies, more recent randomized controlled trials and meta-analyses.
Omega-3 fatty acid medicines in combination with other medicines have been authorized for use after a heart attack in several EU countries since 2000, at a dose of 1 g per day. Available data at the time of their authorization, have shown some benefits in reducing serious heart and blood vessel problems, although the benefits were considered modest. Further data that have become available since then have not confirmed the beneficial effects.
The review concluded that, while a small relative risk reduction was seen in the original open-label GISSI Prevenzione study, these beneficial effects were not confirmed in more recent randomized controlled trials.
Although there are no new safety concerns, the EMA concluded that the benefit-risk balance of these medicines to prevent recurrence of heart disease or stroke is now negative.
Key Takeaways for Patients:
- There are alternative treatment options to prevent recurrence of heart problems after a heart attack.
- If you are using omega-3 fatty acid medicines to reduce the risk of heart problems your doctor will advise on the best alternative treatment option for you.
- There are no new safety concerns associated with the use of omega-3 medicines.
- Omega-3 fatty acid medicines are still authorised to reduce levels of certain types of blood fat called triglycerides. Therefore, if you are using these medicines for this purpose you should
continue your treatment.