Actos Side Effects | Actos Heart Failure

One-Year Anniversary of FDA Actos Cancer Warning

Staff Writer | June 23rd, 2012

It has been over a year since FDA regulators issued a strong public warning about the risks of Actos cancer. The FDA’s June 15, 2011, drug safety communication marked a turning point in public awareness about the health risks associated with Takeda Pharmaceuticals’ widely used Type II diabetes medication. According to the announcement, “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

Public awareness of Actos side effects growing

The FDA’s decision to warn the public of Actos side effects came after several European countries halted sales of the drug and it was recalled in France. More importantly, the FDA reviewed early data from Takeda’s ongoing 10-year Actos cohort study, which involves 193,099 diabetes patients. The data demonstrated that a patient taking Actos for 12 months or more had a 40% increased risk of developing bladder cancer.

Statute of limitations unlikely to affect many

While the FDA warning does not appear to have affected sales of Actos (the drug generated $4.8 billion for Takeda in 2011), it may have played a role in the rapidly growing Actos cancer litigation. Some have speculated that the recent increase in Actos lawsuit filings is related to the anniversary of the FDA announcement, in that the announcement may have started the clock for statute of limitations purposes.

It is unlikely that many plaintiffs have been influenced by the statute of limitations aspect of the anniversary. Few states have one-year limitations periods, and many variables (not just the date of the FDA warning) affect when the limitations period begins to run in any particular case.

Even if the anniversary is considered for limitations purposes, it would not affect claims unrelated to the announcement, such as those of Actos heart failure. All the same, the increased public awareness caused by the warning likely spurred many to seek legal assistance. Thousands of cases are currently pending at the state level in the Illinois mass tort, and at the federal level in the Actos MDL in the U.S. District Court for the Western District of Louisiana.

Patients who believe that they have developed serious side effects from Actos, including Actos heart failure or bladder cancer, have consulted an experienced Actos lawyer to determine if they are eligible to file litigation