Actos and Bladder Cancer
Actos (pioglitazone) is a maintenance medication prescribed to control type 2 diabetes in adults that was approved by the FDA in July 1999. Actos is the most common medication based on pioglitazone and it also marketed under the names of Actoplus Met, Actoplus Met XR and Duetact.
Actos is manufactured by Takeda Pharmaceuticals and Eli Lilly and Company. In 2005, a two-year carcinogenic study was conducted on male and female rats. Results of the study revealed that rats tended to develop drug-induced tumors. Takeda and Eli Lilly were accordingly aware as early as 2005 of the increased risk of cancer associated with the drug but failed to warn consumers. In September 2010, the FDA launched an investigation into the relationship between Actos and bladder cancer. On June 6, 2011, France went further and recalled Actos due to the unreasonable risk of injury. The European Union's European Medicines Agency (EMA) also conducted a review and confirmed the bladder cancer risk, calling for new warning and reviewing every patient who has been prescribed Actos.
The medication, which reportedly grossed $4.8 billion in sales over the year prior to these warnings, remains on the market in the United States but with an enhanced warning informing patients of the risks that they face when using Actos: "Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users. The observational data further suggest that the risk increases with duration of use."
Update (8/04/2011) The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an
increased risk of bladder cancer.
Read FDA Alert
Update (6/15/2011): The FDA is informing the public that use of the diabetes drug Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.
Read FDA Alert
Additional Actos Warning and Side Effects
The FDA has asked the makers of Actos to issue a black box warning, which is the strongest warning recommended by the FDA. This warning relates to the potentially serious link that has been found between Actos and Congestive Heart Failure.
Actos is in a newer class of diabetes drugs, called Thiazolidinedione drugs and has been linked to heart attack, heart failure, and cardiovascular-related deaths. Thiazolidinedione's help to treat Type II diabetes by lowering blood glucose levels, which allow the body to be more receptive to insulin.
Heart-related side effects, including Congestive Heart Failure, are serious concerns for patients with diabetes because the diabetes alone increases the risk of heart-related complications.
- Unusual increase or decrease in weight;
- Edema (swelling);
- Shortness of breath;
- Unexplainable fatigue and weakness;
- Confusion; and
- Chest pain.
Other Actos side effects include:
- Increased risk of bone fractures, particularly in women;
- Increased the risk of suffering liver failure;
- Liver inflammation;
- Elevated liver enzymes (it is recommended that patients using Actos have their liver enzymes checked from time to time); and
If you or a loved one has been injured after taking Actos, please contact Cellino & Barnes. Our drug recall attorneys will evaluate your case for free. Contact an Actos Attorney today. Click Here.