French regulators have suspended the use of Takeda’s diabetes drugs Actos and Competact in the country over fears of an increased risk of bladder cancer in patients taking them.
The French Medicines Agency (Afssaps) made the call after receiving new data from a retrospective cohort study carried out in the country which appears to indicate a slight increased risk of bladder cancer with pioglitazone-containing medicines. Following the French move, German authorities have now informed Takeda that they will take the same measures.
The European Medicines Agency is currently in the midst of a probe into the safety of pioglitazone and a potential link with bladder cancer in patients with diabetes to clarify the drug’s benefit-risk profile, and says it plans to discuss the evidence – including that from the French study – at a meeting later this month.
In the meantime, the Agency is not recommending any changes to the use of pioglitazone-based drugs.
The safety of Actos – which was launched in 2000 and pulls in sales of over $4 billion a year for Takeda – is also under scrutiny across the pond, where US regulators launched an investigation into its potential link with bladder cancer in September last year.
At the time, the US Food and Drug Administration said while early results from a long-term observational study “showed no overall association” there was an increased risk of developing the disease in patients with the longest exposure to Actos “and in those with the highest cumulative dose of the drug”.
