EMA to evaluate cardiovascular risk of high doses of ibuprofen medicines
There is no suggestion of a similar risk when ibuprofen is used in smaller doses and for shorter periods of time
The European Medicines Agency's Pharmacovigilance and Risk Assessment Committee (PRAC) is to evaluate the cardiovascular risks with systemic ibuprofen medicines taken orally.
The review will not include topical ibuprofen medicines such as creams and gels.
The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400mg per day) taken regularly for long periods.
There is no suggestion of a similar cardiovascular risk with ibuprofen as used by the majority of patients, who usually take it in doses of 200–400mg and only for short periods of time.
However, the safety of non-steroidal anti-inflammatory drugs (NSAIDs), which includes ibuprofen, has been under close review by the EMA and national regulatory authorities for many years. Data have suggested that the cardiovascular risk with diclofenac and high-dose ibuprofen (2,400mg) 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.
Ibuprofen works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in inflammation and pain. It is present in medicines as a mixture of two molecules that are enantiomers (mirror images of each other). Dexibuprofen, the active enantiomer, is sometimes available on its own and is therefore included in this review.
Ibuprofen and dexibuprofen are currently available in the European Union (EU) in a number of different formulations. Most are for systemic use, which are covered by the current review. They are available on prescription and over the counter.
As ibuprofen medicines are all authorised nationally, the PRAC recommendation will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.
