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Actos May Raise Bladder Cancer Risk, FDA Concludes in Updated Review

Jan 25, 2017

Actos Still Linked to Bladder Cancer Risk, FDA Says

Actos May Raise Bladder Cancer Risk, FDA Concludes in Review

In an updated review, the U.S. Food and Drug Administration (FDA) said it still believes that use of the type 2 diabetes drug Actos (pioglitazone) may be associated with an increased risk of bladder cancer. The label on drugs containing pioglitazone, including Actos, Actoplus Met, Actoplus Met XR, Duetact and Oseni, will be updated to include information about additional bladder cancer studies, the agency said in a Dec. 12, 2016 notification. The agency previously warned about the possible risk of bladder cancer with Actos in 2010 and 2011.

Parker Waichman LLP has remained actively involved in the Actos bladder cancer litigation. Jerrold S. Parker, founding partner of the firm, has maintained a leadership role throughout the multidistrict litigation (MDL) by serving on the Plaintiff's Steering Committee. The firm is still accepting Actos bladder cancer cases, and continues to offer free legal consultations to individuals with questions about filing an Actos lawsuit.

Regulators first communicated the possible link between Actos and bladder cancer in September 2010 and then in June 2011. The notifications were based on interim results from an ongoing 10-year epidemiological study. In 2010, the agency said that Actos exposure was associated with bladder tumors in animal studies.

In August 2011, the FDA said the label on Actos would be updated to inform patients and physicians about a possible increased risk of bladder cancer. Doctors should not prescribe Actos to patients with active bladder cancer or a history of bladder cancer, the new label cautions. At around the same time, regulators in Europe banned Actos after an epidemiological study in France linked the diabetes drug to an increased risk of bladder cancer. Sales of the drug were suspended in France and German regulators advised healthcare professionals not to start Actos in new patients.

Signs of bladder cancer include blood in the urine, a red color in the urine, a new or worsening urge to urinate or painful urination. If Actos patients experience any of these symptoms, they should speak with their doctor, the FDA said.

In its Dec. 2016 alert, the FDA said it reviewed further research findings analyzing the risk of bladder cancer with Actos. Studies produced mixed results; some found a link while others did not. The 10-year epidemiological study did not identify an increased risk, but another study did. One randomized controlled trial found that Actos was linked to an increased risk of bladder cancer during the study period, but not upon follow-up. “Furthermore, findings of these and other reviewed studies conflicted about whether the duration of use and/or total dose over time of pioglitazone influenced the risk of bladder cancer,” FDA said.

“Overall, the data suggest that pioglitazone use may be linked to an increased risk of bladder cancer,” the agency said.

Actos Bladder Cancer Lawsuit Background

Actos Bladder Cancer Lawsuit Background

Actos was developed by Takeda Pharmaceuticals and Eli Lilly. The companies have been sued over the diabetes drug, with plaintiffs alleging that the drug makers failed to warn patients or physicians about the risks. Thousands of Actos bladder cancer lawsuits have been filed and cases are still being reviewed.

An Actos settlement was proposed in 2015. Takeda agreed to pay $2.4 billion if 97 percent of eligible Actos bladder cancer claimants opted-in to the settlement. Court records show that 8,000 Actos lawsuits were pending in state and federal courts at the time.

Takeda and Eli Lilly have been hit with various Actos verdicts, including a $9 billion verdict handed down by a Louisiana jury. Although both parties expected the award to be reduced post-trial, the sizable verdict gave the companies pause. The verdict was later reduced by 99 percent to $36.8 million. Six months later, Takeda announced its $2.3 billion Actos bladder cancer settlement. The company agreed to raise the settlement amount by $100 million if certain conditions were met. The settlement was offered without admitting liability.

Federal Actos bladder cancer lawsuits are consolidated into an MDL in the U.S. District Court for the Western District of Louisiana before Judge Rebecca F. Doherty. The U.S. Judicial Panel on Multidistrict Litigation (JPML) establishes MDLs when there are lawsuits with common questions of fact. Transferring lawsuits to one court makes the process more efficient. In the Actos MDL, plaintiffs similarly allege that the type 2 diabetes drug contributed to bladder cancer and drug makers knew about these risks but failed to warn patients or the medical community.

Filing an Actos Bladder Cancer Lawsuit

If you or someone you know has questions about filing an Actos bladder cancer lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).


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