More than 24,000 adverse events have been reported to the Food and Drug Administration (FDA) regarding the type 2 diabetes drug Actos since the medication was introduced nearly 14 years ago. The most commonly reported side effect in which Actos is the primary culprit is bladder cancer. Other, less commonly reported side effects reported with Actos include weight gain, fluid retention, congestive heart failure, heart failure, and abnormal liver function.
Actos is a medication used to control blood glucose levels in adults with type 2 diabetes. It is manufactured by Japanese drug company Takeda Pharmaceuticals. In 2011, the FDA issued a warning that studies had linked the medication to bladder cancer, especially in patients who used the drug long term.
In May 2012, the British Medical Journal published a new study analyzing data from more than 115,000 patients treated with diabetes medication. Researchers found that patients taking Actos had an 83 percent increased risk of developing bladder cancer. Two months after the new study was published, the FDA approved generic versions of the drug.
According to AdverseEvents website, the average age of patients who reported problems with Actos is 63, and the average duration of treatment with the drug was 538 days – or about a year and a half.
Actos, or pioglitazone, is a blockbuster medication, generating more than $1 billion in sales in a calendar year.