FDA Approves Generic Actos Despite Risk of Bladder Cancer


FDA Approves Generic Actos Despite Risk of Bladder CancerOverview: Despite the growing body of research linking Actos to bladder cancer, the U.S. Food and Drug Administration (FDA) cleared the first generic version of the drug last Friday. Generic Actos will be manufactured by Mylan Pharmaceuticals in 15 mg, 30 mg and 46 mg doses.



  • The FDA approves the first generic version of Actos (pioglitazone); Mylan Pharmaceuticals will manufacture the drug in 15mg, 30 mg and 45 mg doses
  • Actos has been linked to bladder cancer in many research studies
  • There are a number of lawsuits alleging Actos caused bladder cancer

Product: Actos (pioglitazone)

Manufacturer: Takeda Pharmaceutical/ Eli Lilly & Co.

Side Effects & Complications

  • Bladder Cancer
  • Heart Attacks
  • Cardiovascular Problems
  • Congestive Heart Failure

Generic Actos Has Same Side Effects

Generic Actos will carry the same side effects as the brand name medication. The drug’s safety label will contain information about the increased risk of bladder cancer as well as a “black box” warning about congestive heart failure. However, due to a Supreme Court ruling last year generic drug users cannot sue manufacturers for failing to warn about side effects since the drug makers are not able to change the label. This can have a significant impact, considering the fact that over 70 percent of prescriptions are filled with generics.

Actos Bladder Cancer

Last June, the FDA said that using Actos for one year may raise the risk of developing bladder cancer. At around the same time, sale of the drug was suspended in France and Germany. Since then, research has continued to support the link between the Type 2 diabetes medication and bladder cancer. The most recent study, published last Friday in the Journal of the National Cancer Institute, found that Actos users were two to three times more likely to develop bladder cancer compared to those who took an alternative diabetes drug.

Actos Lawsuits

There are over 10,000 lawsuits in the US claiming Actos caused bladder cancer. Many of these cases have been filed into the multidistrict litigation (MDL no. 2299) as part of the In Re: Actos (pioglitazone) Products Liability Litigation. Jerrold S. Parker, founding partner of Parker Waichman LLP, has been appointed to the Plaintiffs’ Steering Committee.