Actos Bladder Cancer | Actos Recall Europe

Bladder Cancer Risk Sparks European Actos Recall

Seth Harris | July 20th, 2012

Takeda Pharmaceutical’s blockbuster diabetes medication Actos is still sold in the United States, but many critics of the drug contend that its risks far outweigh its benefits. Patient advocates argue that the U.S. Food and Drug Administration (FDA) should follow the lead of European regulators and order a comprehensive Actos recall.

In 2011, the French Public Health Insurance Office published a study revealing that patients taking Actos for 24 months or more face a high risk of developing bladder cancer, a life-threatening condition. Following the report, both France and Germany ordered a recall of the drug. Other countries have followed suit, requiring more explicit warning labels and strictly monitored prescriptions.

While these restrictions have no direct effect on Takeda’s U.S. sales, or FDA’s regulatory decision-making, they may bolster the arguments of Actos lawsuit plaintiffs in U.S. courts.

Actos recall reports benefit plaintiffs

Actos was approved by the FDA in 1999 for the treatment of Type II diabetes, the most common form of diabetes in North America. A decade later, Actos was the tenth best-selling medication in the United States. According to some estimates, Actos generated $4.8 billion in revenue for Takeda Pharmaceuticals in 2010 alone.

Despite the financial success of the drug, growing evidence suggests that patients taking Actos face a 22 percent risk of developing bladder cancer. For the thousands of injured plaintiffs now seeking damages from Takeda, a key element of their legal argument is that the company knew or should have known of the risks of its product, but failed to adequately warn patients of the danger. The fact that regulators in other countries, such as France and Germany, ordered an Actos recall is persuasive evidence of the known risks of the medication.

Longstanding evidence of Actos bladder cancer

Preclinical animal studies first identified the link between Actos and bladder cancer in 2005. Later, a highly publicized study, known as the PROative clinical trial, revealed that patients taking Actos developed bladder cancer at a rate 2.5 times higher than patients receiving a placebo. Finally, a 2011 review of the FDA’s own Adverse Events Reporting System (AERS) demonstrated a “a definite signal for bladder cancer associated with (Actos) use” after six to 24 months of patient exposure.

Combined with the findings from France, Germany, and other countries, there is convincing evidence that Takeda knew of the Actos bladder cancer risks.