EMA starts review of ibuprofen medicines

The EMA has announced that the Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen (i.e., from oral forms).

The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods.  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.