EMA/PRAC recommendations on ibuprofen and bisphosphonates

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400mg per day).

The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union.