FDA launches safety review of Actos

pharmafile | September 20, 2010 | News story | Sales and Marketing Actos, Takeda, diabetes 

A new safety review of Takeda’s diabetes drug Actos has been launched by the FDA after a long-term study suggested a possible link to bladder cancer.

The results are based on five-year data from an ongoing, 10-year observational study by the manufacturer’s US affiliate.

The FDA says early results showed no overall association between Actos (pioglitazone) use and risk of bladder cancer, but there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.

The regulator stressed that it has not concluded there is a definite link between Actos and increased risk of bladder cancer, but the investigation will cast a pall over the drug.

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Actos is in the same glitazone class as GlaxoSmithKline’s Avandia (rosiglitazone) which has been at the centre of its own safety scare since May 2007.

A lengthy FDA investigation concluded this summer that Avandia caused an increased risk of heart attacks, but opted to further restrict its use rather than remove it from the market entirely.

Actos has benefitted from the safety concerns around its rival Avandia, seeing US sales rise as Avandia’s have rapidly declined, but the latest news could hit prescriptions of Takeda’s diabetes brand.

Andrew McConaghie

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