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Parker Waichman wants Takeda to inform public of bladder cancer risk associated with diabetes drug Actos

Filed April 30th, 2012 Laurie

The Food and Drug Administration should compel the makers of the leading Type 2 diabetes drug Actos to issue a stronger warning to doctors and the public about the drug’s association with an increased risk of bladder cancer.

Last year, the FDA issued a Drug Safety Communication stating long-term use of Actos to lower blood sugar levels in diabetics could result in bladder cancer. The national law firm of Parker Waichman LLP believes the agency must go one step further and force Takeda Pharmaceuticals to issue a formal warning linking its drug – especially when used over longer periods of time or at high doses – to an increased risk of bladder cancer.

The first people who’ve been able to link their recent bladder cancer diagnosis to the diabetes drug have already filed suit against Takeda, claiming the drug maker knew its top-selling treatment had already proven to increase the risk a patient would develop bladder cancer. Actos has become the leading Type 2 diabetes drug on the market, especially after the FDA acted to seriously restrict the people who received the previous top-seller, Avandia, which was essentially removed from the market after it was linked to fatal heart attacks and stroke.

Health Canada issued a warning recently officially recognizing the risk of bladder cancer linked with Actos. The law firm the FDA’s time to act has come and said it must force Takeda to better highlight the risk’s addition to the warning labels on Actos. While the warning is contained in that information, the firm of Parker Waichman believes Takeda should be doing more to notify the public of this risk.

“We are hopeful that the FDA will take the strongest action possible to protect patients by requiring Takeda to directly notify the physicians of serious adverse events associated with taking Actos,” states Daniel Burke, attorney at Parker Waichman LLP.

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