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Published on 20 March 2009

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FDA panel approves rivaroxaban pill

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The US drugs watchdog has ruled that the benefits of Johnson & Johnson’s experimental anticlotting drug rivaroxaban outweigh its risks.

The Food and Drug Administration (FDA) panel of cardiology experts has voted 15 to 2 to approve the drug despite incomplete data about possible liver side effects.

If approved – the FDA is not obliged to take the advice of its panellists, though it usually does – it would be the first pill-based anticlotting drug in 50 years.

Studies have shown that rivaroxaban halved the risk of blood clots or death in knee and hip-replacement patients compared with Sanofi-Aventis’s Lovenox, the current standard treatment.

A similar drug from AstraZeneca that is widely prescribed in Europe was never available in the US because it was rejected over fears that it caused liver damage.

But a  majority of panellists ruled in favour of rivaroxaban after noting that it did not appear to cause such damage in the short term.

Said Dr Peter Gross, Professor of medicine at New Jersey Medical School: “I think we have enough safety and efficacy data to approve it for short term use, with the caveat that practitioners should not prescribe it for alternate uses, particularly long-term uses.”

Copyright Press Association 2009

NICE



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