Manufactured by the Takeda Pharmaceutical company, Actos, or pioglitazone, is a drug that, along with diet and exercise, is used to improve blood sugar control in adults suffering from type 2 diabetes mellitus, the most common form of diabetes. Pioglitazone is sold as a single-ingredient product, under the brand name Actos and also in combination with metformin, as Actoplus Met and Actoplus Met XR, and with glimepiride, as Duetact.
Millions of people in the United States alone have been diagnosed with type 2 diabetes, according to the American Diabetes Association. Actos and other pioglitazone-containing products have been prescribed to 2.3 million Americans. After ongoing reports of a possible link between Actos and bladder cancer, the U.S. Food and Drug Administration (FDA) released a safety announcement warning the public of an increased risk of bladder cancer in people with the long-term use of Actos. The manufacturer’s failure to warn doctors and patients of this risk may be cause for legal recourse.
If you or a loved one suffered injuries or developed diabetes while taking Actos, schedule a consultation with a product liability lawyer today. Our Chattanooga Actos injury attorneys could review your case and provide you with guidance as to how to move forward with your case.
A 10-Year Epidemiological Study
After the diabetes medication, Avandia was scrutinized for its heart problem risks, Actos became the new “go-to” type 2 diabetes medication, however, there were questions about its potential risks. In order to conclusively determine whether Actos has any unwarned connection to increased risk of bladder cancer, the FDA began a 10-year study of Actos.
September 2010 FDA Safety Review
A few years lapsed without any news, but in September of 2010, the FDA released a safety announcement indicating that it was reviewing data from the on-going study. In addition, Takeda Pharmaceuticals conducted an analysis of the study at the 5-year mark and handed the results over to the FDA. Overall findings determined that there was “no statistically significant association between Actos exposure and bladder cancer risk.”
Further analyses were conducted on the correlation between bladder cancer risk and a patient’s length of time on the drug, as well as the dosage, however. It was observed that patients with the longest exposure to Actos and those with the highest cumulative doses experienced a greater risk of bladder cancer. Nonetheless, the connection between Actos and bladder cancer was not conclusive at this time and no official warnings were given, though any patient concerned about the risk of bladder cancer was instructed to speak to their doctor.
Less Than a Year After 2010 Safety Review
In June 2011, the FDA released another safety announcement, but this time warning the public that using the diabetes medication Actos for more than one year may increase the risk of bladder cancer. This warning, previously non-existent, has been added to the “Warnings and Precautions” section of the label for all pioglitazone-containing medications. While the FDA continues to evaluate data from the 10-year study, it recommends that healthcare professionals should:
Not prescribe Actos or other pioglitazone medications to patients with active bladder cancer; and
Only use pioglitazone medications with caution for patients with a history of bladder cancer.
Actos in the World
France has also conducted an epidemiological study of Actos and its link to bladder cancer. The results prompted the suspension of all pioglitazone use. Germany is also aware of its risks and has recommended that new patients not be given Actos or any other pioglitazone product. It remains to be seen whether the FDA determines that a suspension or even a recall of Actos is in order.
