Review of ibuprofen medicines started by EMA Pharmacovigilance unit

At its June 2014 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) 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).

Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The review, which follows the PRAC’s work in examining the risks of other medicines of this class, concerns the cardiovascular risks of high-dose ibuprofen (2,400mg 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.

Earlier data has suggested risks similar to COX-2 inhibitors