FDA OK’S Generic Actos In Spite Of Bladder Cancer Risk
As Actos lawsuits mount and concerns about the link between Actos and bladder cancer continue to rise, the U.S. Food and Drug Administration (“FDA”) took an unusual step on August 17, 2012 by approving the first generic version of the popular type 2 diabetes drug.
The decision to approve the Mylan Pharmaceuticals-manufactured pioglitazone tablets has undoubtedly left many baffled, given the staggering amount of adverse event reports by individuals who have experienced side effects such as heart failure, bladder cancer and bone fractures as a result of taking Actos. Not to mention the wave of recent studies linking Actos to bladder cancer. One might wonder why the FDA did not instead address the danger this drug poses to American diabetics by pulling Actos from shelves, as France and Germany did last summer after acknowledging the connection between Actos and bladder cancer.
Manufactured by Takeda Pharmaceuticals, brand-name Actos is a popular medication used to treat type 2 diabetes.
With the FDA’s decision to grant approval for pioglitazone, the agency has reissued its safety guidelines by updating the warning labels on both the brand and the generic form of Actos. Both Actos and its generic form, pioglitazone, are now required to carry Boxed Warning labels emphasizing their potential to cause or worsen heart failure, bone fractures, liver disease, and bladder cancer if used for more than one year.
On the label, the FDA also requires reference to the drug’s common side effects, such as headache, muscle pain, sore throat, respiratory tract infection and sinus infection.
Pioglitazone was approved by the FDA to be marketed in tablets of 15 milligram, 30 mg and 45 mg strengths.
According to recent studies, users most at risk for developing bladder cancer as a result of taking Actos are elderly men over the age of 60.
If you developed bladder cancer as a result of taking Actos, you may be eligible to file an Actos lawsuit against the manufacturer. The attorneys at Bernstein Liebhard LLP are currently investigating and evaluating claims on behalf of individuals who developed bladder cancer as a result of using Actos. Peruse our website to learn more about Actos lawsuits or contact us directly at (877) 779-1414.