December 5, 2011 — Takeda Pharmaceutical Co., the largest pharmaceutical company in Asia, is under increasing pressure regarding its diabetes drug, Actos (generic: pioglitazone) which has been linked to an increased risk of life-threatening side effects, including bladder cancer, heart attacks, and stroke. According to a Bloomberg news report, Takeda may face up to 10,000 lawsuits, and a group of U.S. judges is currently deciding where to consolidate the litigation into a single federal court.
Actos has been the most popular diabetes drug on the market since a 2007 study linked Avandia, a rival diabetes pill sold by GlaxoSmithKline Plc, to a higher risk of heart attacks. In 2010, Actos sales reached $4.3 billion globally, and accounted for 51.8% of Takeda’s U.S. sales, and 27% of the Osaka-based company’s total revenue. Actos belongs to a new class of diabetes medications, known as thiazolidinediones, which work by increasing the body’s sensitivity to insulin. The FDA approved Actos in 1999 to control blood sugar in adults with Type 2 diabetes. An estimated 2.3 million patients filled a prescription for Actos in 2010.
News of an impending, massive litigation in the U.S. comes in the wake of several major setbacks for Takeda. French authorities suspended sales of Actos in May 2011, citing an increased risk of bladder cancer. Germany followed soon after, advising patients not to start the medication. In June 2011, the U.S. FDA issued a safety announcement after finding that Actos increased a patient’s risk of bladder cancer if it was taken for at least one year at high doses.
Several recent studies have linked Actos to an increased risk of bladder cancer. The first was a French study that followed users from 2006 through 2009. Findings from this study prompted French medical regulators to withdraw approval. Actos’s manufacturer is currently conducting a 10-year study of the drug; though the study is incomplete, results at the five-year mark indicate an increased risk of bladder cancer, in accordance with the results of other studies.
Takeda is currently updating the drug’s prescribing information to include new warnings about an increased risk of bladder cancer, which is particularly notable for people who have a history of bladder cancer. Actos has not been linked to an increased risk of developing other types of cancer.
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