Actos Lawsuits Over Bladder Cancer Are Gaining Steam

Recent reports suggest that thousands of Actos lawsuits are likely to be filed in courts across the country by individuals who developed bladder cancer after using the popular diabetes drug. 

The impending flood began earlier this month, with the first lawsuits over bladder cancer from Actos being filed against Takeda Pharmaceuticals, alleging that the drug maker knew or should have known that long-term use of Actos increases the risk of bladder cancer.

According to a recent report by the Associated Press, several law firms already represent more than 100 clients who are considering a potential Actos bladder cancer lawsuit, and the number of cases is expected to continue to grow as Actos lawyers run advertisements to inform individuals who developed bladder cancer that they may be able to pursue compensation through a lawsuit.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increased the body’s sensitivity to insulin. The medication has grown in popularity in recent years, after studies linked it’s primary competitor, Avandia, to an increased risk of heart attacks and death. Last year, Actos generated $4.3 billion in sales for Takeda Pharmaceuticals.

Last week, the FDA approved language for new warnings that Takeda is now providing about the potential risk of bladder cancer from side effects of Actos.

The updated drug label will now 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 also 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.

FDA officials began reviewing the potential risk of Actos bladder cancer problems 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, an Actos recall was issued in France 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.

As more and more former users of the medication learn about the link between Actos and bladder cancer, it is expected that the number of lawsuits will continue to increase.