US advocacy group calls for Takeda gout drug to be pulled from the market

A Japanese-developed treatment for gout, which was twice rejected by the US medicines regulator, has come under fire from the not-for-profit consumer advocacy group Public Citizen.

The US Food and Drug Administration should immediately remove from the market the widely used gout medication febuxostat because it poses unique, serious risks – some fatal – for no unique benefit, Public Citizen said yesterday in a citizen petition to the agency.

There is “overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit,” the petition states. Leaving it on the market ensures “further preventable harm” to patients.