Type 2 diabetes is the most frequently occurring form of diabetes in which a person suffers from high levels of sugar (glucose) in the blood. According to the National Center for Biotechnology Information (NCBI), as a lifelong disease, type 2 diabetes requires that an individual receive timely and effective treatment. In many cases, type 2 diabetes patients will be prescribed medication to help manage how the body makes or uses insulin so as to prevent high levels of sugar accumulating in the blood (hyerglycemia). Actos (pioglitazone), manufactured by Takeda Pharmaceuticals, is such a medication. From January 2010 to October 2010, about 2.3 million patients filled a prescription for Actos to help treat the symptoms of type 2 diabetes. However, on June 16, 2011, the U.S. Food and Drug Administration (FDA) issued a warning that use of Actos for over one year may raise a person's risk of developing bladder cancer.
Actos was approved by the FDA on July 15, 1999 to be taken in conjunction with an altered diet and exercise plan to enhance glycemic control for type 2 diabetes patients. It was sold as a single-ingredient product under the brand-name Actos as well as combined with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). When the FDA announced its warning about the potential association of prolonged use of Actos and bladder cancer, it was also stated that data regarding Actos bladder cancer risks will be placed on the Warnings and Precautions section of the label for pioglitazone-containing drugs. In addition, the patient Medication Guide for these drugs has been updated to contain information on the risk of bladder cancer.
Although these new warnings are essential, they may have come too late for some type 2 diabetes patients who now suffer from bladder cancer as a result of taking the medication without knowing of the potential side effects.
The FDA warnings were derived from a planned five-year interim analysis of a continuous, ten-year epidemiological study that was highlighted in a September 2010 FDA ongoing safety review. Based on the study results, even though there was no conclusive evidence connecting a heightened risk of bladder cancer with pioglitazone use overall, it was concluded that patients who had taken pioglitazone the longest and patients who had taken the highest overall dose of pioglitazone were at a greater risk of developing bladder cancer.
Bladder cancer warnings for Actos have not only been distributed in the United States. According to the FDA, a recent epidemiological study in France emphasizes a heightened risk of bladder cancer with pioglitazone, prompting the country to suspended pioglitazone use. Moreover, new patients are not advised to start using pioglitazone in Germany.
The FDA has advised that medical professionals not use pioglitazone in patients who have active bladder cancer. The FDA has also recommended that pioglitazone be used carefully in patients who have a history of bladder cancer. Overall, the benefits of blood sugar control with Actos or other pioglitazone medications must be weighed against the indefinite and possible risks for cancer returning.
As a patient, you trust that the medications prescribed to you are safe and will not cause you further harm. Unfortunately, doctors can even be deceived by drug manufacturers who fail to conduct thorough tests and who neglect to identify all potential side effects before a drug is put on the market. If you or someone you care about has bladder cancer and was or is taking Actos or another pioglitazone-containing drug, it is probably prudent to investigate the merits of a possible hazardous drug claim. At Blume Forte, our New Jersey drug injury lawyers have years of experience evaluating pharmaceutical defect claims. For more information and a no-cost consultation, please call (973) 635-5400.
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