In June of 2011, France medical regulators took the diabetes drug Actos off the shelves in a nationwide Actos recall. The move came after a review of French public insurance data that showed a link between Actos and bladder cancer. Might the U.S. follow suit with an American Actos recall?
Actos Recall in France Alerts the World to the Issue
An estimated 230,000 people in France took the drug Actos for treatment of type 2 diabetes. The French Medicines Agency found a 22 percent higher risk of bladder cancer in patients taking it between 2006 and 2009, compared to patients not taking the drug. In those patients taking the drug for longer than a year, the increased risk was 34 percent. Because of these findings, the agency ordered an Actos bladder cancer recall.
Following France's Actos recall in 2011, and based on their study results, the German Federal Institute for Drugs and Medical Devices recommended that their healthcare professionals refrain from prescribing any more Actos to patients. They stopped short of an Actos recall, however, allowing those patients already taking the drug the option to continue.
Actos Recall 2011 Spreads to Europe
After the Actos recall in France and the recommendation in Germany, the European Medicines Agency (EMA) announced that it was reviewing the data. Many expected that they, too, might follow up with an Actos bladder cancer recall, but the EMA did not go that far. On October 21, they stated they would not recommend an Actos recall, indicating that Actos is still a valid treatment for diabetes, but recommended that the drug be used only as a last resort.
Forecast for an Actos Recall in the U.S.
While all this was going on in Europe, the U.S. was performing its own investigation into the link between Actos and bladder cancer. After evaluating the five-year results of an ongoing 10-year study, the FDA concluded that patients taking Actos for longer than a year, or taking particularly high doses, were at a 40 percent increased risk of Actos bladder cancer. They issued a warning alerting physicians and the public to the findings in June 2011, adding that they would continue to review the study results, and that they would also review the results of the French study.
Critics have called for an Actos bladder cancer recall in the U.S., but so far the FDA has given no indication that it intends to implement such a recall. Whether or not future study results may change that remains to be seen.
An Actos Recall Lawyer May be Able to Help
If you or a loved one has suffered from an injury caused by Actos, you may be eligible for compensation in an Actos recall lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.