Actos Cancer Warning Update Approved by FDA

The FDA has approved new warning language about the risk of bladder cancer from Actos, a blockbuster diabetes drug sold by Takeda Pharmaceuticals.

In a Drug Safety Communication issued last week, the FDA released the final language for the new Actos cancer warning, indicating that patients who use the diabetes drug for more than a year may face an increased risk of bladder cancer.

The updated drug label recommends that healthcare providers not use Actos in patients with active bladder cancer and exercise caution with patients who have a history of bladder cancer.

Patients already taking Actos are being advised to immediately notify their doctor if they develop blood or red color in their urine, urgent needs to urinate, pain while urinating or pain in the back or lower abdomen, which could be early signs of bladder cancer.

In addition to Actos, the new bladder cancer warnings will also be carried on ActoPlus Met, ActoPlus Met XR and Duetact, which all contain pioglitazone as an active ingredient.

Actos (pioglitazone) 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.

FDA officials began reviewing the potential Actos bladder cancer side effects in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the study conducted by Takeda Pharmaceuticals, the makers of Actos, indicated that after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

In June, France and Germany issued an Actos recall after a review of public insurance data identified an increased incidence of bladder cancer with Actos use. The European Union’s European Medicines Agency (EMA) also conducted a review and confirmed the bladder cancer risk, calling for new warnings and a six-month review of every patient on Actos. The EMA suggested that Actos bladder cancer risk could be reduced by appropriate patient selection and exclusion.

Last week, one of the first Actos bladder cancer lawsuit 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. It is expected that many other complaints will be filed in the coming weeks and months, as Actos lawyers throughout the U.S. are continuing to review and investigate potential cases for individuals diagnosed with bladder cancer.