EMA Highlights: Watchdog to review high-dose ibuprofen

by Gary Finnegan – The European Medicines Agency (EMA) is reviewing the cardiovascular risks of systemic ibuprofen medicines. The focus is expected to be on tablets taken by mouth rather than topical ibuprofen products such as 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.

The medicines watchdog said there is 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, a non-steroidal anti-inflammatory drug (NSAID), has been closely watched by national and European regulators for several years. 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. Last year, the EMA considered the available data relating to diclofenac and issued recommendations to minimise the risks.

The Agency’s pharmacovigilance committee is expected to evaluate evidence on the interaction of ibuprofen with low-dose aspirin to decide whether current advice to healthcare professionals is sufficient.

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