Takeda Pharmaceuticals, the largest pharmaceutical company in Asia, faces yet another recent Actos bladder cancer risk lawsuit in the U.S. District Court of Florida over allegations that the company’s type-2 diabetes medication causes a possible two-fold increased risk of bladder cancer.

Plaintiffs Jay R. and Robin R. file the Actos bladder cancer risk lawsuit over adverse side effects they blame on this medication.

According to their Actos lawsuit, Jay says that in 2009 he was prescribed Actos, taken regularly upon his physician’s direction, to assist in his treatment and long-term maintenance of type-2 diabetes. However, in June 2017 and as a “direct result of ingestion of Actos,” Jay says that he was diagnosed with bladder cancer.

He says that because of his condition, he has suffered from emotional distress, economic loss due to medical expenses, and severe physical and mental pain and suffering.

Jay says that had he known of the potentially dangerous side effects of the medication, particularly in causing increased risks for bladder cancer, he would have never taken or used Actos to begin with.

His Actos bladder cancer risk lawsuit was filed against the manufacturer on multiple counts including strict liability, negligence, breach of express warranty, breach of implied warranty, and loss of consortium.

Overview: Actos Bladder Cancer Risk Lawsuit

Actos (pioglitazone) is an antidiabetic medication prescribed to treat type-2 diabetes.

Actos was approved by the U.S. Food and Drug Administration (FDA) in 1999. However, this was amid numerous restrictions and warnings against its approval. These issues were raised because of the drug’s possible two-fold risk in causing bladder cancer, bone fracture, and increased risk for kidney disease and lactic acidosis.

More than 10,000 lawsuits have been filed by plaintiffs for injuries suffered from Actos against the drug’s manufacturer, Takeda Pharmaceuticals, and the drug’s co-marketer Eli Lilly, a U.S. based pharmaceutical company. In fact, Takeda agreed to settle many of those claims for a total of $2.4 billion in 2015.

For much of the drug’s history it’s been a top-selling antidiabetic medication. Between 2007 to 2011 it averaged sales of nearly $3 to $4 billion per year and accounted for almost 25 percent of Takeda’s revenue.

However, animal clinical studies conducted prior to the drug’s approval have shown that the drug’s active ingredient leads to increased bladder tumors in male rats. Another three year safety study conducted after the drug’s approval showed risks of bladder cancer in humans.

Due to the results of these studies, the FDA required Takeda to conduct an additional 10-year Actos bladder cancer risk study.

After interim results were released from that study at the five-year mark, the FDA required Takeda to increase its warnings of Actos bladder cancer risk. Results finalize prior reports that there is in fact increased risks of Actos bladder cancer associated with the medication.

Actos allegedly poses additional adverse side effects causing permanent, life-threatening, and harmful risks such as:

• Bone Fracture Risks
• Congestive Heart Failure
• Chronic Kidney Disease
• Macular Edema

The Actos Bladder Cancer Risk Lawsuit is Case No. 1:18-cv-24955-RNS in the U.S. District Court for the Southern District of Florida.