When Did Actos Come on the Market?
Actos is a prescription drug containing Pioglitazone Hydrochloride. This medication, manufactured by Takeda pharmaceuticals was approved by the FDA in July 1999 to treat diabetes. Since its introduction to the market, Actos was the subject of a 10 year study to measure the safety and side effects. At the 5-year interval, results showed that although there was no overall increase of bladder cancer from Actos – there was an increased risk of bladder cancer noted among patients who had the longest exposure to Actos and were exposed to the highest cumulative dose of Actos. However, following the completion of the 10 year study, on June 15, 2011, the FDA issued a safety alert informing the public that using the diabetes Actos for more than one year may put patients at a higher risk for bladder cancer.
In Europe, a French Study also suggested an increase risk of bladder cancer from Actos. France has suspended the use of Actos as a result.
As per the safety alert, the “FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.”
I graduated Cum Laude from Temple University's Fox School of Business and Management in 2007. Having concentrated in Marketing, I am happy to begin my career blogging at one of Philadelphia's most prominent law firms, Anapol Schwartz. Jackie Fedeli→