California Actos Side Effects Attorney

The FDA approved Actos for treatment of diabetes in 1999, but complaints associated with bladder cancer have continued through the years.

Actos, which is used along with diet and exercise to treat Type 2 diabetes, is available in several forms, including Actoplus Met, Actoplus Met XR and Duetact. Actos is one of Takeda's top-selling drugs. In 2011, Actos had sales of over $4 billion and accounted for 27% of Takeda's revenue. It has been estimated that over 2.3 million prescriptions for medications containing pioglitazone were filled in 2010.

In September 2010 the FDA ordered a safety review of Actos. The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos. A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

In August 2011 a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer. A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a "disproportionate risk" of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.

A European study also found an increase in bladder cancer in those taking Actos.