Actos Recall Issued in France Due To Risk of Bladder Cancer

A month after French regulators suspended sales of their popular diabetes drug due to concerns about an increased risk of bladder cancer, Takeda Pharmaceuticals has agreed to issue an Actos recall in France. However, there is no indication that the drug maker is going to voluntarily take similar action in the United States.

Actos (pioglitazone) was approved in the U.S. in July 1999, for treatment of type 2 diabetes. The medication is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.

In June, regulators in France and Germany announced that sales of the drug were being suspended due to a potential risk of bladder cancer from Actos.

Takeda Pharmaceuticals has now agreed to recall Actos in France after being pressured by Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS). The related drug Campetact, which is sold as Actoplus Met in the United States, will also be recalled in France.

The potential bladder cancer side effects of Actos are still being reviewed by regulators in the rest of the European Union, Canada and by the FDA in the United States, after studies have shown an increased risk of bladder cancer with Actos

Last month, the FDA announced that new Actos bladder cancer warnings will be added to the drug’s label, alerting users about the potential increased risk if the drug is used for more than one year. All drugs containing pioglitazone, the active ingredient in Actos, will carry the new warning, including Actoplus Met, ActoplusMet RX and Duetact. However, the U.S. regulatory agency is continuing to weigh the potential risk of bladder cancer from Actos against the benefits provided by the medication.

The FDA first announced that there may be a possible connection between bladder cancer and Actos in September 2010, after preliminary data from an on-going 10 year study suggested that there may be an increased risk the longer the drug is taken.

In May 2011, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records. However, that study did not establish a causal effect between Actos and bladder cancer.

Concerns about an Actos bladder cancer risk increased even further last month, after a review of insurance data on 1.5 million French citizens identified an increased occurrence of bladder cancer among Actos users.

Throughout the United States, a number of former users of Actos diagnosed with bladder cancer are not considering filing potential lawsuits against Takeda Pharmaceuticals for failing to fully research the side effects of the medication or adequately warn about the risk of bladder cancer.