After reviewing the new drug safety & pharmacovigilance data, the French national drug regulator, AFSSAPS, has suspended the use of Takeda Pharmaceuticals' diabetes drug-(pioglitazone/ActosTM)-for bladder cancer risks.
These drugs were taken by an estimated 230,000 patient in France. The decision was taken based on some 1.5 million post-market data examined by the national French insurer between 2006 to 2009. Actos was approved in Europe in 2000 as an option for patients who do not benefit from metformin, a standard treatment, or metformin and insulin.
Meanwhile, the US FDA initiated an ongoing 10-year epidemiological study to determine the post-market benefit vs. risk assessment, particularly on Actos’ SAE and its causality with bladder cancer. In the latest issue of Diabetes Care, it identified 93 cases of bladder cancer among Actos patients in the FDA AERS database between 2004 and 2009, with the authors claimed that the Reporting Odds Ratio was indicative of a definite risk for Actos. Copy of the abstract available here.
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