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Possible Actos Bladder Cancer Risk Gets Attention of U.K. Regulators

Jun 14, 2011 | Parker Waichman LLP

Actos (pioglitazone) continues to be the subject of scrutiny, as yet another European regulator is set to take a look at whether or not patients using the diabetes drug face a higher risk of bladder cancer. According to an report, regulators in the U.K. are set to take up the Actos bladder cancer issue on Thursday.

Just last week, regulators in France and Germany decided to suspend sales of Actos after a French study found that people taking Actos had a 22 percent higher risk of bladder cancer compared to those taking other drugs. Those taking the highest cumulative dose - 28,000 mg or more - faced the highest risk. The study followed 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics. 

An unnamed source in the U.K. told that it is likely that "pioglitazone does cause a problem with bladder cancer, probably growth promotion."

On June 20, the European regulator, the Committee for Medicinal Products for Human Use (CHMP), will also meet to assess the Actos bladder cancer issue, said.

In the U.S, the Food & Drug Administration (FDA)
has been looking at the Actos bladder cancer risk since  2010, after early data from another  study found d that those taking the highest dose of the drug, and those taking it for the longest time, had a higher risk of bladder cancer.

The FDA has not commented on the latest French study, but according to a Reuters report, Takeda Pharmaceuticals said last week that the agency has made no indication that it will ask for an Actos recall.

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