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the popular diabetes drug Actos has been linked to an increased risk of bladder cancer. Health regulators in several foreign countries have suspended sales of the drug and the FDA required new warnings about the potential risk of bladder cancer from Actos in June 2011.
STATUS OF ACTOS BLADDER CANCER LAWSUITS: As a result of the manufacturer’s failure to adequately research the side effects of Actos or warn about the risk of bladder cancer, compensation may be available through an Actos lawsuit.
MANUFACTURER: Takeda Pharmaceuticals
OVERVIEW: Actos (pioglitazone) was approved by the FDA in July 1999 as a treatment for type 2 diabetes. It is part of the same class of drugs as Avandia (rosiglitazone), which has been linked to an increased risk of heart attacks and other health problems. In recent years, use of Actos has increased as some studies have suggested that the diabetes medication may be safer than Avandia.
Some studies suggest that Actos side effects may increase the risk of bladder cancer the longer the medications is taken.
BLADDER CANCER SIDE EFFECTS OF ACTOS: The FDA announced that they were reviewing and evaluating the Actos bladder cancer risk in September 2010, after preliminary data from an on-going 10 year study conducted by Takeda Pharmaceuticals suggested that users of the diabetes drug may face an increased risk of cancer when the medication is taken for more than a year.
In May 2011, a new study was published that provided further evidence that suggests Actos side effects may increase the risk of bladder cancer. Looking at adverse event reports made to the FDA, researchers found that about one-fifth of all reports involving bladder cancer among diabetes drug users involved Actos. Although the study does not establish a causal effect between Actos and bladder cancer, researchers suggested that there may be a disproportionate risk in comparison to other diabetes drugs.
Drug regulators in France and Germany decided to suspend sales of the drug, essentially issuing an Actos recall, in June 2011, after a review of public insurance data revealed an increased occurrence of bladder cancer.
On June 16, 2011, the FDA announced that new warnings about the risk of bladder cancer from Actos will be added to the medication label in the warnings and precautions section. Similar warnings will also be added to other medications that contain pioglitazone, the active ingredient in Actos; including, Actoplus Met, ActoplusMet XR and Duetact.
Since then, several additional studies have further confirmed the link between Actos and cancer. A June 2012 study published in the British Medical Journal found that Actos may double the risk of bladder cancer after two years, and another study presented at the American Society of Clinical Oncology’s annual meeting in May 2012 suggested that the risk may apply to all drugs belonging to the same class of medications, known as thiazolidinediones, which also includes Avandia and Rezulin.
A study published in the Journal of the National Cancer Institute in August 2012 found that Actos users may face triple the risk of cancer when the medication is used for longer than five years.
ACTOS BLADDER CANCER LITIGATION: As of mid-2013, Takeda Pharmaceuticals faces thousands of Actos bladder cancer lawsuits in courts throughout the United States, which have been filed by patients who allege that the drug maker failed to adequately warn the medical community or patients about the drug’s side effects.
In the federal court system, all complaints have been consolidated for pretrial proceedings as part of an Actos MDL, or multidistrict litigation, which is centralized before U.S. District Judge Rebecca Doherty in the Western District of Louisiana.
A number of claims have also been filed at the state level.
In early 2013, the first trial in the country was held in California state court involving a man who developed bladder cancer in November 2011, following two years of Actos use. That case was given an expedited trial date under California procedural rules, due to his grave health condition. Following more than two months of trial, a Los Angeles jury awarded $6.5 million in damages in the Actos case, finding that Takeda Pharmaceuticals failed to adequately warn about the potential side effects of their blockbuster diabetes drug. However, the judge who presided over the trial subsequently overturned the damage award after excluding key expert witness testimony offered at trial to establish that side effects of Actos were the cause of this specific plaintiff’s bladder cancer diagnosis.
Additional cases are scheduled to begin in federal court in January 2014 and April 2014, serving as “bellwether” trials to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout a number of lawsuits. The outcomes of these early trials may influence negotiations to settle Actos cases nationwide.