Bladder cancer risk of Takeda's Actos now highlighted by US FDA

16 June 2011

The latest bad news for Japan’s largest drugmaker, Takeda Pharmaceutical (TYO: 4502) came last night with a warning from the US Food and Drug Administration that its blockbuster diabetes drug Actos (pioglitazone) when used for more than one year may be associated with an increased risk of bladder cancer.

The announcement comes just days after French and German regulators pulled Actos off their respective markets on similar concerns about the safety of the drug, which is co-marketed in the USA with Eli Lilly (NYSE: LLY) and generated sales of $4.8 billion for Takeda in the last fiscal year (The Pharma Letter June 10). The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is reviewing the safety of Actos this week, and the European Medicines Agency is also looking into the safety issue.

Pioglitazone is also marketed by Takeda in combination with metformin as Actoplus Met and Acotplus Met XR and with glimepride as Duetact. US sales of the drug make up around 75% of its total turnover.

Takeda remains confident on drug’s therapeutic benefit

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