PharmExec Blog

EMA to Review Safety of Ibuprofen Medicines

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.

The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. There is no suggestion of similar cardiovascular risk in lower doses taken for short periods of time. Long available as an over-the-counter medicine in Europe, ibuprofen has a well-known safety profile.

However,  safety of non-steroidal anti-inflammatory drugs (NSAIDs) has been under close EMA review for many years. 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).

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.


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