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European regulator launches review of high-dose ibuprofen safety

Europe’s drug regulator is set to review the cardiovascular safety of ibuprofen taken regularly at high doses.

The European Medicine Agency (EMA) said its Pharmacovigilance and Risk Assessment Committee (PRAC) will look at the cardiovascular risk of systemic ibuprofen at doses of 2,400 mg per day ‘taken regularly for long periods’.

The move comes after the EMA placed restrictions on prescribing of diclofenac – another NSAID commonly used for musculoskeletal problems – last year, meaning the drug could no longer be prescribed to people with vascular disease.

The EMA said in a statement: ‘Data, in particular the results of a published analysis of clinical trial data, have suggested that the cardiovascular risk with diclofenac and high-dose ibuprofen (2,400 mg) may be similar to the known risk with COX-2 inhibitors (also of the NSAID class).’

‘In 2013, the PRAC considered the available data relating to diclofenac and issue recommendations to minimise their risks. The PRAC is now considering the available data relating to high-dose ibuprofen.’

In addition, the EMA said it will evaluate evidence on the interaction of ibuprofen and low-dose aspirin ‘to decide whether current advice to healthcare professionals is sufficient’.

It said patients should continue to take ibuprofen as directed by their GP or pharmacist, or according to package instructions, while the review is ongoing.


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