FDA Links Actos to Bladder Cancer and Issues New Warning

Actos (generic pioglitazone hydrochloride) is an oral medication used for treatment of Type 2 diabetes. Recent research suggests that users may face an increased risk of bladder cancer from Actos side effects the longer the medication is taken. The FDA announced a new Actos bladder cancer warning in June, after interim data from a review of 193,099 diabetics revealed that those taking the drug for more than a year had a 40 percent increased risk for bladder cancer. The 10 year study on which the new warnings are based will

be completed in 2012. The FDA’s announcement came just days after regulators in France and Germany suspended Actos sales. Those decisions were made after a study of more than 1 million diabetics – including 155,000 on Actos and 1.3 million on other medications – that was commissioned by the French government found that Actos patients faced nearly a 22 percent higher risk of bladder cancer compared to those taking other drugs.

Concerns about the potential risk of Actos cancer side effects first surfaced when it was discovered that rats given the drug had a higher rate of bladder tumors. Recent results from an on-going 10 year study, involving nearly 200,000 patients with diabetes, suggests that there may be a risk of bladder cancer from Actos the longer the medication is taken. The FDA announced in September 2010 that Takeda Pharmaceuticals, the manufacturer of Actos, provided interim data after five years that suggests there may be a risk of bladder cancer from Actos side effects the longer the medication is used. After 24 months, the rate of exposure and the increased Actos cancer risk reached statistical significance.

Actos was approved by the 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. Last month, one of the first Actos lawsuits in response to the drug causing a plaintiffs bladder cancer was filed against Takeda Pharmaceuticals by a California man who developed an aggressive form of the cancer after taking the diabetes drug for two years.