According to a clinical study in France, there is an increased risk of bladder cancer associated with Takeda’s drug Actos (pioglitazone). Surveying 1.5 million diabetic patients, this study also found that the risk of bladder cancer sharply increased with usage of over 12 months as well as with increased dosage. Prior to the study conducted in France, bladder cancer was similarly observed in male rats receiving clinical equivalent doses of (Actos) pioglitazone.
As a consequence of these findings, Takeda’s Actos will be completely removed from the pharmaceutical market in France. Similarly, the German Federal Institute for Drugs and Medical Devices has already advised doctors to cease in prescribing Actos to their diabetic patients. While Actos is still currently available in the United States, the FDA has been conducting rigorous safety reviews of the drug and further exploring its alarming and devastating link to bladder cancer.
Additionally, the United States FDA has reacted to the findings of the Actos Study in France by amending the warnings and precautions section of all Actos drug labels to reflect it’s dangerous and previously unreported correlation to bladder cancer. As of 8-4-2011, the FDA announced that their approval of the inclusion that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. Because Takeda first introduced Actos into the market in the 1990’s, this means that many diabetes patients have been using this drug for decades without knowledge of its devastating risk of leading to bladder cancer.
In response to the French data, the FDA declared that healthcare professionals should not prescribe Actos (pioglitazone) to patients with active bladder cancer. In addition, Actos should be used with caution in patients with a prior history of bladder cancer because the benefits of blood sugar control must be carefully weighed against the risks for bladder cancer recurrence.
The hugely popular Actos has ranked among the top ten selling prescription medicines in the United States. In 2010 Actos had sales of over $3.4 billion, and accounted for 27% of Takeda Pharmaceuticals revenue. However, after the alarming results of the recent study in France, the usage of Actos for Diabetes must be carefully weighed against its link to bladder cancer. In the words of Dr. Harlan Krumholz, a Yale School of Medicine professor, “The consensus already is that (Actos) should only be considered … after patients have exhausted all other options.”
If you or one of your family members took Takeda Pharmaceutical’s drug Actos (pioglitazone) and have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at our law firm can inform and assist you regarding legal action in a potential Actos bladder cancer lawsuit against the makers of the drug.
Please fill out our online legal evaluation form to the right or call 1-800-883-9858 and we will contact you within 4-12 hours for a free confidential case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.