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Takeda Put Actos Profits Ahead of Consumer Safety, Lawyer Says

Sep 4, 2013

In the second case to go to trial over the cancer risks of the diabetes drug Actos, a lawyer argued that Takeda Pharmaceutical Co. put sales ahead of safety by failing to warn consumers about the drug’s risks.

In state court in Baltimore, an attorney for the family of Diep An, who died of bladder cancer in 2012, said Takeda officials knew by 2005 that studies had shown links between Actos (pioglitazone) and bladder cancer, but the company didn’t issue a warning until six years later, Bloomberg News reports. An’s family blames Actos for the fatal cancer the former Army translator developed.

Court filings in An’s lawsuit say he took Actos beginning in 2007 to treat Type 2 diabetes and was diagnosed with “high-grade bladder cancer” in September 2011, according to Bloomberg News. He died in January 2012.

In a 2001 review of a company-sponsored study, officials of the U.S. Food and Drug Administration (FDA) found that some Actos users faced an increased risk of developing bladder cancer or heart problems. The drug was pulled off the market in Germany and France that year, at the request of those countries’ regulators, Bloomberg News reports. In June 2011, based on five-year data from an ongoing epidemiological study, the FDA issued a warning that taking Actos for more than a year could significantly increase the risk of bladder cancer. The agency required an update of the Actos label to address this risk.

More than 1,200 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges, according to Bloomberg News. The first federal case is set for trial in January 2014.

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