Actos and bladder cancer

The FDA has updated drug labels for Actos, usually prescribed to treat Type 2 diabetes, to state that the use of the drug for more than one year may be associated with an increased risk of bladder cancer. Actos, manufactured by Takeda, has been under FDA review since September 2010. In June 2011, the FDA issued a warning for Actos.

At the same time, in June 2011, drug regulators in France and Germany suspended the use of Actos. The ban came in the wake of a French study, conducted by the nation’s health insurance agency, which examined cancer rates in approximately 155,000 people taking pioglitazone in France from 2006 to 2009, and 1.3 million other diabetics who were not receiving the agent.

The FDA began a review of Actos and cancer risk in September 2010, when the agency issued a safety announcement suggesting a potential risk with Actos. Although it concluded that there was not significant reason to remove the drug from use, the FDA reported in its data summary that “the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure.”

Doctors in France and Germany have been advised to stop prescribing Actos.

Actos Lawsuits

Actos lawsuits filed in federal courts have been consolidated under Judge Rebecca Doherty in U.S. District Court for the Western District of Louisiana. Lawsuits claim Takeda and Eli Lilly misrepresented and omitted information it held about Actos and “actively concealed its risks.” The lawsuits also claim Plaintiffs were not adequately warned about Actos risks and could have taken several safer alternative drugs had they known about the health risks posed by Actos.

On April 8, a federal jury in Lafayette, La., ordered the drug’s manufacturer, Takeda Pharmaceutical Co., and its partner, Eli Lilly & Co., to pay a combined $9 million in punitive damages. The jury found the drug makers knew about the cancer risks associated with Actos, but hid those risks from the public. This was the first federal trial in this litigation. The case was filed on behalf of Terrence Allen and his wife, Susan. Mr. Allen contracted bladder cancer after using Actos. In addition to the punitive damages, the jury also awarded the Allens $1.5 million in actual damages.

Andy Birchfield, who is head of the Mass Torts section at Beasley Allen law firm, has been appointed to the Plaintiffs’ Steering Committee for the consolidated litigation. This committee assisted in preparations for the Allen trial. Reacting to the verdict, Birchfield said, “Thousands of people have bladder cancer as a result of the egregious conduct of these drug companies regarding Actos,” said Beasley Allen lawyer Andy Birchfield, who is head of the firm’s Mass Torts section. “As long as potential drug sales are wildly lucrative, companies will face the temptation to ignore or hide serious safety concerns. This verdict sends a clear message for companies to beware; there is accountability in the courts.”