The European Medicines Agency (EMA) has confirmed that high doses of ibuprofen and related molecule dexibuprofen carry a small increased risk of cardiovascular diseases, such as heart attack and stroke.

A high dose of ibuprofen is defined as 2,400mg or more per day. No increased risk was found at up to 1,200mg, which is generally the highest dose for over-the-counter oral preparations in the EU. For dexibuprofen (the active enantiomer of ibuprofen), which is used alone or in combination with ibuprofen, a high dose is defined as 1,200mg or above.

As a result — and in line with the class warning already in place for non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors and diclofenac — the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that product information and dosing guidelines be updated to reflect the risks.

The PRAC’s position, announced on 13 April 2015, follows a comprehensive safety review begun in June 2014 at the request of the UK’s Medicines and Healthcare products Regulatory Agency. It considered systemic (oral and intravenous) dosing, but not topical applications (gels and sprays).