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Victims from Australia and New Zealand who claim to have taken Actos and then developed bladder cancer are now joining a new class action lawsuit taking place in the U.S. seeking to hold drug maker Takeda liable for alleged Actos injuries.

Lead plaintiff Peter Marshall, from Bisbane, Australia, alleges that he took Actos for about a year and a half before he was diagnosed with bladder cancer. He states that Takeda failed to provide adequate warnings about the risks to patients in Australia, and that the warnings they did eventually provide in 2011 were even weaker than those applied in the U.S.

Takeda Late in Providing Actos Warnings

The FDA approved Actos in 1999, but it wasn’t until 2011 that the product label mentioned the risk of bladder cancer in the U.S. On June 15, 2011 the FDA warned that those taking the diabetes drug for over a year may have an increased risk of the disease, based on the five-year results of a 10-year epidemiological study. Patients using the drug for long-term maintenance of type 2 diabetes had a 40 percent increased risk of bladder cancer.

Takeda implemented an Actos recall in France in 2011. In Germany, the health regulatory agency restricted the use of the drug after discovering the risks. But in Australia, the drug remained available, though with a new warning about bladder cancer that was added in 2011. It stated the “use of…pioglitazone, for more than a year may be associated with an increased risk of bladder cancer.” The news led to a significant drop in Actos prescriptions, from over 430,000 in 2011 to around 379,000 in 2012.

Actos Lawsuits Likely to Increase

Already over 3,000 actions have been filed against Takeda in the U.S., but with tens of thousands of Australians and New Zealanders thought to have taken the drug, the number of people with claims may soon increase substantially. Claimants are likely to point to animal studies conducted by the company that indicated a risk of tumors long before the drug was released on the market.

“They knew before they even released the drug that it had a tendency to induce tumours in rats but they proceeded irrespective of that,” said Marshall’s Actos lawyer

Marshall had undergone treatment for his bladder cancer and is now in remission, but has been told the cancer may return. He has stated that he wasn’t sure about taking Actos in the first place, but decided it would be best to prevent problems with his type 2 diabetes later in life. The cancer diagnosis was a complete shock.

“I wouldn’t want anyone else to have to go through what I have,” he said.

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