Evidence in favour of naproxen heart risk fails to bring label change

In spite of a meta-analysis of trial data published in The Lancet – which suggested naproxen had a lower vascular risk compared with competitive non-steroidal anti-inflammatory drugs – the evidence has not swayed an FDA panel to vote in favour of changing the drug’s labelling.

The recommendation, from a vote of 16 to 9 against, affects Bayer’s Aleve painkiller, and is likely to be adopted by a final decision by the US regulator.

“Our meta-analysis, which is unaffected by selection and other biases inherent in observational studies, showed clearly that the vascular risks of diclofenac, and possibly ibuprofen, are similar to coxibs, but that naproxen is not associated with an increased risk of major vascular events.”

Coxib and traditional NSAID Trialists’ Collaboration.



Related news:

Panel votes down heart safety claim for naproxen (ABC News/AP).

FDA panel says Aleve should keep its heart-risk warning (FiercePharma).

FDA panel says data does not support lower heart risk of naproxen (Reuters).

Reference link:

Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials (The Lancet).

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