Pioglitazone, manufactured by Takeda Pharmaceutical Company as Actos, has been a popular medication used to treat type 2 diabetes mellitus, a condition in which the body is unable to adequately process insulin. Actos increases the body’s response to insulin, a natural substance that controls blood sugar levels. Actos is known to be associated with the development of congestive heart failure, heart attack, liver damage and macular edema.A series of warning announcements have been issued by the United States Food and Drug Administration, known as the FDA, concerning an increased risk of bladder cancer associated with the drug as well as other . Although the FDA has not issued an official recall of Actos, studies continue to explore the linkage of the drug with the development of bladder cancer. The FDA has required that strict warnings be placed on prescribing labels for all medications containing pioglitazone.

Several Safety of Health Products agencies withdrew Actos from the market due to reported cases of bladder cancer. German Health Agencies advised physicians against prescribing Actos until further cancer risk analyses had been conducted. The recalls of Actos by French and German regulators have prompted other European countries to launch scientific investigations into reports of bladder cancer caused by Actos. Shortly after French officials suspended all sales of Actos, Takeda Pharmaceutical Company voluntarily issued a recall in that country. There have been no indications that Takeda is planning to take similar action in the United States. Canadian health officials have recently launched an extensive investigation concerning the risks of bladder cancer associated with Actos; however, definitive action has not been taken to suspend sales of the drug. Despite warnings from multi-national agencies, sales of Actos have been permitted to continue.

According to a recent article published by the Associated Press, “The maker of the world’s best-selling diabetes drug is facing hundreds of lawsuits as suspicion grows regarding the risk of bladder cancer…” Since publication of the article, thousands of lawsuits have been filed in federal and state jurisdictions in the United States.

Actos lawsuits filed against Takeda Pharmaceutical Company allege the company was aware of the risks of bladder cancer associated with the drug, yet failed to inform medical professionals and consumers of the risks. The company’s failure to warn has resulted in the filing of multiple class action, personal injury and product liability lawsuits. Lawsuits allege the company continued to aggressively promote and market Actos as an effective and safe treatment for type 2 diabetes, despite multiple warnings regarding the drug’s linkage to bladder cancer. The company’s failure to warn the public of risks associated with Actos has resulted in negligence claims alleging fraud and deceit. Takeda may be found to be in breach of express and implied warranties by continuing to manufacture and market Actos. Takeda aggressively disputes allegations of wrongdoing and plans vigorous defenses against lawsuits stemming from a myriad of complications related to Actos.

After use of the diabetes drug Avandia was limited by the FDA due to concerns regarding heart disorders, lawsuits mounted and are currently being litigated in federal and state jurisdictions. GlaxoSmithKline, the manufacturer of Avandia has reportedly settled 10,000 lawsuits filed against the company and has set aside reserves in amounts reaching $400 million to settle thousands of pending cases. There is no indication that Takeda Pharmaceutical Company is taking responsibility for injuries and deaths due to complications caused by Actos.