European medical officials are calling for new warnings about the risk of bladder cancer from Actos to be added to Takeda Pharmaceutical’s popular diabetes drug.
The European Medicines Agency completed a review of the potential Actos cancer side effects this week and announced that they will not call for an Actos recall across the entire European Union.
Although France and Germany have already recalled the drug after a study found an increased incidence of bladder cancer among Actos users, the EMA indicates that new warnings are sufficient to allow the medication to remain on the market.
The FDA is also conducting an on-going review of the potential link between Actos and bladder cancer, but indicated last month that new warnings about the potential Actos cancer risk would be added to the medication in the United States.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) confirmed the bladder cancer risk, but determined that the benefits of Actos for some type 2 diabetics still outweighs the potential health problems. The CHMP’s statement said that the risk of cancer from Actos could be reduced by appropriate patient selection and exclusion, which would include a requirement for a three to six-month review of the drug’s performance for each individual patient.
The CHMP has called for a pan-European epidemiological study to harvest more data on the risk, focusing on whether the risk increases with age and duration of use, to better minimize the threat to patients.
Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.
Sales have increased in recent years, after a number of studies have suggested that Actos may be safer than its primary competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths.
Since information about the risk associated with Actos, a number of former users in the U.S. are planning to file an Actos cancer lawsuit against Takeda Pharmaceuticals for failing to fully research the side effects of Actos or adequately warn about the potential risk of cancer.