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Naproxen should have CV safety warning removed, says US regulator


The evidence on the cardiovascular safety of naproxen is now strong enough to state that it does not increase the risk of CV thrombotic events, according to review from the US drug regulator.

The reviewers from the US Food and Drug Administration (FDA) state that evidence published since 2006 suggest naproxen does not pose the same CV risks as other NSAIDs.

They recommend that the ‘black-box’ safety warning – added to all NSAIDs in the US in 2005 after the withdrawal of rofecoxib – should now be removed from naproxen.

A key piece of data was a UK study published in The Lancet last year which suggested the vascular risks of high-dose diclofenac, and possibly ibuprofen, are comparable to cox-2 inhibitors, whereas high-dose naproxen is associated with less vascular risk than other NSAIDs.

The review states: ‘This study reinforces the 2005 conclusions by FDA that the risk for CV events is present for both nonselective and cox-2 selective NSAIDs but also raises the possibility that, in contrast to the 2005 conclusions, there may be a lower risk for one NSAID, naproxen.’

The MHRA guidance currently says: ‘There is some evidence that naproxen may have a lower risk of heart attacks or strokes than selective cox-2 inhibitors.’

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