December 5, 2011 — The manufacturers of the diabetes drug Actos (generic: pioglitazone) are potentially facing a massive litigation in the United States. Takeda Pharmaceutical Co., Asia’s largest pharmaceutical company, may face up to 10,000 lawsuits in the U.S. over claims that the drug causes serious, life-threatening side effects, such as bladder cancer, heart attacks, and strokes. A group of judges in the U.S. is currently deciding which federal court will be used to consolidate the lawsuits into a single class-action.

Pressure on Takeda has been building since several studies found that people who take Actos for at least one year and at high doses have a much higher risk of developing bladder cancer. The risk is higher for people who have a history of bladder cancer, and the risk is not increased for other types of cancer.

Actos is currently the most popular diabetes drug on the market. Ironically, Actos became the preferred diabetes medication when a study in 2007 found that Avandia, a rival diabetes drug manufactured by GlaxoSmithCline, increased a user’s risk of heart attacks. The FDA approved Actos in 1999 for the treatment of Type 2 Diabetes. Actos belongs to a new class of diabetes medications known as thiazolidinediones, which work by increasing the a patient’s sensitivity to insulin. An estimated 2.3 million Americans filled prescriptions for Actos in 2010. In the same year, sales reached $4.3 billion globally. These sales figures made up 27% of Takeda’s total revenue, and 51.8% of U.S. sales.

The impending, massive litigation against Takeda in the U.S. is just the latest woe for the pharmaceutical company. The European Medical Agency (EMA) is in the process of updating safety information to include warnings about bladder cancer, after a French study raised safety concerns. The study followed users from 2006 through 2009, and the findings prompted French authorities to suspended sales of Actos in May 2011. Soon after, Germany advised new patients not to begin the medication. The U.S. Food and Drug Administration (FDA) issued a safety announcement and has updated safety labeling information. Takeda Pharmaceuticals is currently in the process of conducting a 10-year study of the drug; the findings at five years indicate an increased risk of bladder cancer — similar to other studies.

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