Actos Lawsuits Could Number in the Tens of Thousands

Houston, TXA recent report suggests that Actos side effects could result in 10,000 or more Actos lawsuits being filed against Takeda Pharmaceutical Co. Among reported side effects are a potential link between Actos and bladder cancer, and it is that link that has some patients angry.

According to Bloomberg (11/30/11), up to 10,000 Actos lawsuits concerning the reported increased risk of bladder cancer may be filed by patients in the US. Actos is currently a top-selling diabetes medication, after rival drug, Avandia, had its sales severely limited by the US Food and Drug Administration due to concerns about an increased risk of heart attacks. Following that, however, came reports that Actos could be linked to an increased risk of bladder cancer.

One attorney, speaking with Bloomberg said his firm represents 1,200 Actos patients and they expect thousands more. US courts are now in the process of determining where Actos bladder cancer lawsuits should be consolidated. A September court filing by Takeda, maker of Actos, indicated the company has faced 54 Actos lawsuits in US federal courts, although experts expect more will be filed.

Patients who have filed lawsuits say they would not have taken Actos if they had known about the increased risk of cancer associated with the medication. What sets Actos lawsuits apart from Avandia lawsuits, according to experts quoted by Bloomberg, is the distinctive nature of Actos injuries. Avandia side effects, which reportedly include an increased risk of heart problems, are associated with many other conditions, making it difficult to trace a heart problem back to Avandia use. Bladder cancer, which is at the core of the Actos lawsuits, is not associated with many other causes, making it easier to pinpoint to Actos use.

Actos has already been pulled off the market in Germany and France, also due to concerns about the increased risk of bladder cancer.

In June 2011, the FDA issued a warning that use of Actos for more than one year could be associated with an increased risk of bladder cancer. At the time, the agency noted that the warning label for Actos would be updated to reflect the new information. The warning was issued after the FDA completed its five-year interim analysis of a 10-year epidemiological study on the safety of Actos. In its FDA Drug Safety Communication (06/15/11), the FDA noted that although there was no overall increased risk of bladder cancer associated with pioglitazone use, there was an increase seen in patients who had the longest exposure to the drug and the highest cumulative dose.

Patients who take Actos and experience blood in the urine, urinary urgency, pain when urinating, or back or abdominal pain are urged to seek medical attention.