Actos Risks Post Potential Threats at Same Rate as Avandia

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year. Sales have increased in recent years since a number of studies have suggested that Actos side effects appeared safer than its competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths. Some experts and even federal regulators have called for an Avandia recall, which would likely lead to even greater use of Actos to treat diabetes, possibly increasing the risk of Actos bladder cancer sufferers. In 2005 results from the PROactive Study (PROspectivePioglitAzone Clinical Trial in Macro Vascular Events) demonstrated a higher percentage of  bladder cancer cases with Actos use than in competitors’ drugs following three years of research leading victims to file an Actos lawsuit. That information was not included when the study’s findings were published.

A study, which took place in British Columbia, Canada, appears in the August 10/24, 2009 issue of the Archives of Internal Medicine. TZDs(thiazolidinediones) are a class of diabetes drugs that includes Actos. The study looked at fracture risk in over 84,000 patients who received Avandia (rosiglitazone) or Actos (pioglitazone) over a sulfonylurea.

The study revealed that men and women experienced an increased risk of fractures when taking a TZD and found that Actos could actually be responsible for an increased fracture risk.TheFDA asked for a warning on the Actos labeling two years ago to address the fracture risk.

The latest study in the journal Lancet found heart failure risks for those taking Actos are greatest for patients with a history of heart disease and heart failure, but less for those who had no heart problems. Overall the relative risk was 72 percent higher. In addition, concerns about the potential risk of Actos cancer side effects first surfaced when it was discovered that rats given the drug had a higher rate of bladder tumors. Recent results from an on-going 10 year study, involving nearly 200,000 patients with diabetes, suggests that there may be a risk of bladder cancer from Actos the longer the medication is taken.In June 2011, an Actos recall was issued in France after health authorities ordered doctors to stop prescribing the drug due to the possible risk of bladder cancer.