FDA Approves Actos Bladder Cancer Warning

Baltimore, MDWith news that the US Food and Drug Administration (FDA) was strengthening the warnings about the risk of Actos bladder cancer came news that lawsuits were being filed alleging Actos side effects. Concern about a link between Actos and bladder cancer led to the FDA's warning, while patients allege they were not adequately warned about the risks associated with Actos.

Actos, like rival drug Avandia, is used to treat type 2 diabetes. Avandia was subject to stringent restrictions on its use after a panel of experts determined that the risks of Avandia were too high to recommend the drug for general use. From that point on, Actos appeared to be the drug to take Avandia's place.

The FDA's warning about Actos, however, may put a damper on that. According to the FDA, "the use of pioglitazone [the generic name for Actos] for more than one year may be associated with an increased risk of bladder cancer" (08/04/11). As of August 2011, the FDA has approved stronger warning labels, alerting patients to the potential risk of bladder cancer in long-term use of Actos. Patients are urged to contact a healthcare professional if they experience blood in their urine or pain on urination.

The updated labels were requested after an interim analysis of a 10-year study on Actos found that there was an increased risk of bladder cancer in patients who had the longest exposure to pioglitazone and those who had the highest cumulative dose of the medicine. As a result of the study, France stopped the use of pioglitazone while Germany recommended no new patients be put on the medicine.

The FDA has not taken as drastic of steps concerning Actos, recommending instead that the drug not be used in patients who have active bladder cancer and be used with caution in patients who have a prior history of bladder cancer. In making its announcement, the FDA noted that there was no overall increased risk of bladder cancer with pioglitazone use, but there was an increased risk among patients with the longest use or the highest cumulative dose.

According to The Clinical Advisor (08/08/11), the study involved approximately 200,000 patients with diabetes who took Actos and showed approximately a 40 percent increased risk of bladder cancer in patients who took the drug for more than a year.

Lawsuits have reportedly been filed against Takeda Pharmaceuticals Co. Ltd, alleging that patients developed bladder cancer after using Actos.