Manufacturers, user facilities and importers of medical devices are mandated to submit certain adverse events to the U.S. Food and Drug Administration [FDA]. Medical device reporting requires that manufacturers report to the FDA when they learn that one of their...
Actos Diabetes Drug
Actos, Takeda, and Now Omontys
Takeda, who is defending itself in the Actos litigation where type 2 diabetics have higher than anticipated occurrence of bladder cancer, may be on the verge of another blockbuster drug gone awry. Recent reports in the Wall Street Journal indicate that the...
Bladder Cancer Shown In Actos Side Effect Studies
The FDA approved Actos for treatment of diabetes in 1999, but complaints associated with bladder cancer have continued through the years. In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side...
Actos Recalls in France and Germany:
Although ACTOS is still being sold in the US, two leading European countries stopped sales of the drug. A June 2011 European clinical study by the French National Health Insurance plan found a statistically significant risk of bladder cancer among 1.5 million...