Takeda’s Actos, the diabetes drug, has been linked to possible cases of bladder cancer. After studies established a connection between the drug and disease, the widely used medication was taken off the shelves in two European countries last June. Shortly after, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) addressed the possible causal relationship between Actos and bladder cancer. In the wake of these developments, Takeda may find themselves amidst numerous lawsuits.
Actos, or pioglitazone, is prescribed to patients with Type 2 diabetes, a disease that over 25 million Americans have, according to CBS News. Actos works by increasing the body’s insulin sensitivity in attempt to regulate blood sugar levels. It belongs to a class of drugs known as thiazolidinedione (TZD). This is not the first time the TZD class has raised health concerns; GlaxoSmithKline’s Avandia became highly controversial when it was linked to heart problems. Comparatively, it had appeared that Actos was the safer option. Actos has been the best-selling diabetes drug in the world as well as Takeda’s top-selling medication. The popular drug helped the Japanese-based manufacturer accumulate about 387.9 billion yen, or $4.8 billion, last fiscal year. This accounts for 27 percent of the company’s total revenues.
Actos was banned from France and Germany after government-funded research, which followed diabetic patients taking Actos from 2006 to 2009, discovered that the drug lead to an increased risk of bladder cancer. The FDA began a 10-year study of the drug in 2010, in response to similarly disturbing reports. So far, an interim review indicates a possible increased risk of bladder cancer for patients who have been taking the drug for more than a year. In July 2011, the EMA also commented on the matter, stating that the manufacturer should include a warning that makes clear the relationship between Actos and bladder cancer. Both agencies have acknowledged the risks, but so far neither has pulled the drug off the market completely.
Now, Takeda may be involved in as many as 10,000 lawsuits over Actos. Takeda has already been sued in federal courts 54 times because of the diabetes drug, company lawyers said last September. One of the cases included Terrence Allen, a warehouse worker who took the drug for 5 years before being diagnosed with bladder cancer in January 2011. “If somebody had told me I could get cancer from Actos, I never would have taken it,” he said in a telephone interview with Bloomberg Businessweek. He pointed out that “There were other products out there that could have helped treat my diabetes without putting me through all of this.” Considering the extent of litigation that Takeda may face, Allen is certainly not alone.
Despite these developments, Takeda maintains that Actos still plays a useful role in treating diabetics. The company defended itself by stating, “Takeda already revised the information on risks regarding bladder cancer on leaflets in the U.S. and Japan and is in the process of updating in Europe,” additionally, “Takeda remains confident on the efficacy of pioglitazone for treating type 2 diabetes, while it continues to monitor the safety profile of the medicine.” But given all that’s happened, one can only wonder how long it might be before Actos is banned completely.