European Actos Recall Limited to France
In the wake of the Actos recall in France and the suspension of sales in Germany that took place in June 2011, many expected the European Medicines Agency (EMA) to follow suit. They stated at the time that they were reviewing the evidence. Meanwhile, in the U.S., the phrase “Actos bladder cancer lawsuit” became familiar as victims started coming forward complaining of the injury. Over the past few months, Actos lawsuits have steadily increased, causing many to speculate about a future Actos recall, either in Europe or the U.S.
On October 21, however, the EMA stated that it would not recommend an Actos recall.
Actos recall in France starts the ball rolling
After reviewing study data for over a year, the FDA released a drug safety communication in June 2011 warning healthcare practitioners of the link between diabetes drug Actos and bladder cancer. A five-year interim analysis of a 10-year study found that patients exposed for more than a year had an increased risk of 40 percent.
In August 2011, the first Actos bladder cancer lawsuit was filed in the U.S. Meanwhile, France was busy taking Actos off the shelves in its Actos recall. Data from the French National Health Insurance Plan showed a significant increase in bladder cancer in patients who took Actos compared to those who took other diabetes medications. Germany took heed of the study results in France and advised their physicians not to prescribe the drug to any new patients. They stopped short of implementing an Actos recall, however.
Why will Europe continue to sell Actos?
Since France and Germany took such serious steps to protect the public from Actos, many were surprised at Europe’s decision to continue to allow the drug to be sold. In a statement validating their stance on the drug, the EMA indicated that Actos is still a valid diabetes treatment. Because of the risk for bladder cancer, however, they recommended it be used only when other treatments fail.
The motivation behind this move is to continue to allow patients who have been unable to control their diabetes through other methods the option to try Actos. Now that the risk of Actos bladder cancer is widely known, the EMA feels that patients will be adequately informed, and that some may still benefit from use of the drug. They have also warned physicians to be sure to monitor patients for any signs of Actos bladder cancer.
More victims filing an Actos bladder cancer lawsuit
Actos lawsuits continue to increase in the U.S., with plaintiffs claiming manufacturer Takeda failed to adequately warn of the serious health risks. The U.S. Judicial Panel on Multidistrict Litigation (MDL) is currently considering consolidating every Actos bladder cancer lawsuit into one court for pre-trial proceedings, which would heighten efficiency and cut costs. The panel is scheduled to meet on December 1, 2011 on the issue.