Review to evaluate cardiovascular risk with high doses taken over long periods

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels).

The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time.

There is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.

Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The safety of these medicines including their cardiovascular risks has been under close review by the EMA and national regulatory authorities for many years. Data, in particular the results of a published analysis of clinical trial data, have suggested that the cardiovascular risk with diclofenac and high-dose ibuprofen (2,400 mg) may be similar to the known risk with COX-2 inhibitors (also of the NSAID class). In 2013, the PRAC considered the available data relating to diclofenac and issued recommendations to minimise their risks. The PRAC is now considering the available data relating to high-dose ibuprofen.

The PRAC will also evaluate evidence on the interaction of ibuprofen with low-dose aspirin (taken to reduce the risk of heart attacks and strokes) to decide whether current advice to healthcare professionals is sufficient.

While the review is ongoing, patients should continue to use their medicines as per the instructions in the package leaflets or as directed by their doctor or pharmacist.


Posted on the EMA website on 13 June 2014