High-dose ibuprofen faces European regulator review

The European drug regulator will review the safety of high-dose oral ibuprofen after a study suggested long-term use may increase risk of cardiovascular problems.

Ibuprofen medicines face a safety review for potential cardiovascular risks (Photo: SPL)
Ibuprofen medicines face a safety review for potential cardiovascular risks (Photo: SPL)

The European Medicines Agency (EMA) will scrutinise the safety of systemic ibuprofen medicines containing at least 2,400mg and taken over long periods.

It follows clinical trial data that suggested the cardiovascular risks of high-dose ibuprofen or diclofenac may be similar to the known risk from COX-2 inhibitors, or 'coxibs', which have been previously linked to a slightly raised risk of MI and stroke.

A meta-analysis published in The Lancet last August found a one-third increase in the relative risk of major vascular events from diclofenac or coxibs, while high-dose ibuprofen increased the risk of major coronary events.

The EMA said there was no suggestion of a similar cardiovascular risk from lower-dose ibuprofen most commonly used by patients.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which will conduct the safety review, has previously issued advice to minimise risks from diclofenac in response to the concerns.

The PRAC will also look at the evidence on the interaction of ibuprofen with low-dose aspirin to determine whether advice to GPs and other health professionals needs updating.

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