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Actos Allowed to Stay on the Market in Europe

Jul 25, 2011 | Parker Waichman LLP

After months of clinical review, the European Medicine Agency has decided to keep Actos on the market despite recent studies that show the drug is associated with a small, increased risk of bladder cancer, reported the San Francisco Chronicle.

In a statement on its website, the European agency said the benefits of Actos outweigh any risks posed to patients with Type 2 diabetes.

Actos was approved in 1999, to lower glycemic levels in adults with Type 2 diabetes.  The drug is currently Takeda’s best-selling product generating $5 billion in 2010.

The U.S. Food & Drug Administration (FDA) has also been reviewing the risks associated with Actos. On June 15, the agency released a safety announcement informing consumers there is an increased risk of bladder cancer in those taking Actos for more than one year.  The FDA based its warning on an interim review of an on-going, ten-year epidemiological study.

In 2010, the FDA reported that researchers found an increased risk among those taking Actos for at least two years and in patients exposed to the highest cumulative dose of the drug.

According to a report by the San Francisco Chronicle, some physicians have already stopped prescribing Actos.

Actos and other drugs in its class, including Avandia, are also associated with fluid retention, weight gain and bone loss, Neale Cohoen, an endocrinologist at the Baker IDI Heart and Diabetes Institute in Melbourne, told the San Francisco Chronicle.

French medicine regulators banned Actos from their market in June, after study results showed the drug was linked to an increased risk of bladder cancer.  The French Health Products Safety Agency also announced Takeda’s drugs Actos and Compectact would be withdrawn in the country based on the same  French study.  German regulators also suspended the sale of Actos.

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