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Drug safety

EMA reviews safety of high-dose ibuprofen

The European Medicines Agency (EMA) has launched a safety review to weigh up the cardiovascular risk posed by taking high doses of ibuprofen, the anti-inflammatory analgesic.

Ibuprofen tablets

Ibuprofen tablets

There is no cardiovascular risk associated with the usual ibuprofen dose taken short-term

The review was prompted by concerns by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency, that the drug, when taken in high doses over a long period, may have the same cardiovascular risk as that associated with cyclo-oxygenase-2 (COX-2) inhibitors.

The EMA points out that the risk assessment only relates to long-term regular use of the drug, taken in tablet form, at a daily dose of 2,400mg.

It is not looking at ibuprofen gels or creams. 

The EMA will also examine the interaction of ibuprofen with low-dose aspirin when taken to reduce the risk of stroke and heart attack and consider whether it needs to issue new safety advice.

The potential cardiovascular risk of drugs such as ibuprofen — a non-steroidal anti-inflammatory — has been considered and under review for years, according to the EMA.

The latest review, which pertains to high-dose ibuprofen taken over an extended time, follows a similar analysis in 2013 of the long-term cardiovascular risk of taking high doses of the anti-inflammatory, diclofenac. That review led to new safety recommendations.

The EMA says there is no cardiovascular risk associated with the usual ibuprofen dose for adults and children over 12 years of age — 200mg to 400mg, three or four times a day as needed — a dose usually taken short-term.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065481

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