18.06.2019 - Implementation of the implementing decision

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission (2019) 4336 dated 06.06.2019 by decision of the 14th June 2019. This concludes the European risk assessment procedure in accordance with Article 31 of Directive 2001/83/EC on omega-3 acid ethyl esters (EMEA/H/A -31/1464). The opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency thus becomes legally binding.

The Committee, as a consequence, considers that the benefit-risk balance of Omega-3 acid ethyl esters medicinal products for oral use in secondary prevention after myocardial infarction is not favourable.

In addition to the decision to request the pharmaceutical companies to update the product information, a declaratory decision was also sent in the case of cancelled marketing authorisations to terminate marketability.

29.03.2019 - Renewed CHMP opinion

EMA confirms that omega-3 fatty acid medicines are not effective in preventing further heart disease after a heart attack.

14.12.2018 - CHMP opinion

Omega-3 fatty acid medicines are no longer considered effective in the prevention of heart disease

22.03.2018 - Procedure started

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC regarding the use of omega-3 fatty acid medicines after heart attacks.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Omega-3 acid ethyl esters-containing medicinal products for oral in use in prevention after myocardial infarction