Side Effects of Actos May Increase Risk of Kidney Disease: Study

As debate continues about the link between the use of Actos and bladder cancer, new research suggest that the popular diabetes drug may increase the risk of chronic kidney disease.  

In a study published earlier this year in the medical journal PLoS One, Taiwanese researchers indicate that they failed to find a link with bladder cancer, but did discover an association with increased rates of kidney disease among Actos users.

Researchers reviewed data involving nearly 35,000 people identified through the National Health Insurance Research Database in 2003, with follow-up from 2005 to 2009. The study looked at patients who started using Actos in 2003 after never having used the drug before, then went back to compare rates of bladder cancer and kidney disease.

The researchers found that those who took Actos were about three times more likely than those who did not use the drug to be diagnosed with newly developed chronic kidney disease. However, the difference in the rate of bladder cancer was not statistically significant.

Actos Bladder Cancer Lawsuits

The findings come as Takeda Pharmaceutical faces thousands of Actos lawsuits filed by former users of the diabetes drug who indicate that they have been diagnosed with bladder cancer. The claims allege that the drug maker failed to provide adequate warnings about the potential risk of cancer that has been associated with long-term use of the medication in several studies in recent years.

Concerns about the Actos bladder cancer risk first emerged in 2010, following a study by French insurers that found increased rates of tumors among users of the diabetes drug.

In August 2011, the FDA required new warnings to be placed on the medication about the risk of bladder cancer, indicating that individuals who use the diabetes drug for more than a year may face an increased risk. However, plaintiffs allege that Takeda Pharmaceuticals should have provided warnings much earlier.

At least three cases have already gone to trial before state court juries, with conflicting results.

In May 2013, a California jury awarded $6.5 million in damages over Actos bladder cancer in a case brought by Jack Cooper, who was given an expedited trial date due to his grave health. However, following post-trial motions, that verdict was reversed after the state court judge excluded the plaintiffs’ expert witness testimony.

A second trial was held in Maryland state court in September 2013, which resulted in a jury finding that Takeda failed to adequately warn about the risk of bladder cancer from Actos and awarding $1.77 million in damages. However, the case resulted in a defense verdict for the drug maker under a unique Maryland law, known as contributory negligence, as the jury also found that the plaintiff failed to exercise reasonable care for his own health, which nullified the negligence of the drug maker.

A third Actos bladder cancer trial recently concluded in Nevada state court, which resulted in a defense verdict after the jury determined that both Actos and the plaintiff’s history as a smoker contributed to the development of bladder cancer. In that case, the plaintiff also ordered generic versions of Actos from online pharmacies, which raised questions as to whether Actos or unknown factors in the generic versions purchased online could have contributed to the development of the disease in that case.

There are currently at least two other Actos trials currently continuing, and are being closely watched by lawyers involved in the litigation.

A case in Nevada state court began earlier this month, involving a combined trial for lawsuits filed by two women; Delores Cipriano, 81, and Bertha Triana, 80. Both plaintiffs claim that they were diagnosed with bladder cancer after using Actos for treatment of type 2 diabetes, and both have undergone multiple surgeries to remove tumors.

In the federal court system, the first Actos bellwether trial is still continuing in Louisiana, where all cases filed in U.S. District Courts throughout the country have been centralized for coordinated handling during pretrial proceedings. This case is the first of two bellwether trials that have been scheduled to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout other cases.

Following a series of bellwether cases in the federal Multidistrict Litigation (MDL), if the parties fail to reach Actos settlement agreements to resolve large numbers of cases, individual lawsuits may be remanded back to U.S. District Courts throughout the country for multiple simultaneous trials nationwide.