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Actos Problems with Bladder Cancer Cause Sales to Fall: Report

New FDA warnings and growing concerns about the link between Actos and bladder cancer appear to be cutting into Takeda Pharmaceutical Co.’s bottom line, with the company experiencing substantial drops in profits amid falling Actos sales.

Japan’s largest drug maker announced a net profit of $1.74 billion for the six months prior to the end of September and the company estimates that by March 2012, it will have seen a 31 percent drop in profits.

The majority of those losses are being attributed to the fall of Actos, a diabetes drug that has been linked to an increased risk of bladder cancer over the last year.

Takeda, which is nearly 30% owned by foreign investors, has seen its shares drop 13% since January. The loss in profits and share value come despite strong sales of the diabetes drug Nesina and the cancer drug Vectibex.

Actos (pioglitazone) was introduced as a treatment option for type 2 diabetes in July, 1999. Until recently, it was Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.

The Actos problems with bladder cancer first surfaced in September 2010, when FDA officials released an early communication about interim data from an on-going 10 year study that found Actos users may face an increased risk the longer they take the drug.

In June 2011, France required a recall of Actos after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.

In the United States, new Actos cancer warnings were approved by the FDA in August 2011, indicating that patients who use the drug for more than a year may face an increased risk of bladder cancer.

Takeda’s problems with Actos do not appear to have an end in sight. In recent months, a growing number of individuals throughout the United States have filed an Actos lawsuit against the drug maker, alleging that it failed to provide adequately warnings for consumers or the medical community about the risk of bladder cancer. Many of the complaints indicate that Takeda should have recalled Actos from the market, arguing that the risk of bladder cancer outweighs the minimal benefits.

Hundreds of cases filed by individuals diagnosed with bladder cancer after using the diabetes drug may ultimately be included as part of the Actos litigation in the United States. A panel of judges is scheduled to meet on December 1 to decide whether all federal Actos lawsuits should be consolidated as part of an MDL, or multidistrict litigation.