European Recalls of Diabetes Drug a Sign of Things to Come?

The battle to treat diabetes has taken on a new level of challenge as evidence linking the popular drug Actos with an increased risk of bladder cancer continues to mount. The results of a preliminary study by the Food and Drug Administration (FDA) in June found that those taking Actos were at a higher risk of developing the serious disease.

Actos is the trade name of the drug pioglitazone and is manufactured by Japanese-based Takeda Pharmaceuticals Co. It is used to treat type 2 diabetes and is the highest-selling diabetes medication in the world, with $4.8 billion in sales during the last fiscal year. In the U.S., the company used Eli Lilly & Co. to market the product from July 1999 through March 2006.

Initial results from a 10-year study by the manufacturer did not produce any meaningful link between the drug and the development of bladder cancer. However, when the FDA reviewed information from the five-year interim data period, it discovered that some users who took the drug over a longer period of time developed an increased risk of the disease. The analysis looked at 193,099 patients treated with Actos, with a median use of two years. The epidemiological study has run since 2002, with data to be collected through 2012.

In response, the company says it has revised information it includes with the drug to note the risks of bladder cancer. The drug remains on the market in the U.S., despite the fact that Takeda removed it from the market in France and Germany following discovery of the link. The company has committed to continue its investigation and research into potential safety concerns.

Actos is not the only diabetes drug to face scrutiny. Previously, the popular drug Avandia was linked with an increased risk of stroke and heart attack. Its use has been strictly limited in the U.S. and its manufacturer, London-based GlaxoSmithKline plc, has spent more than $6 billion on legal costs associated with the severe risks of the drug. Following the news of issues with Avandia, sales of Actos spiked as doctors switched patients away from the drug with known risks.

Despite Actos' continued availability, several lawsuits have been filed against Takeda and Eli Lilly alleging harm resulting from its use. One unique aspect of the case against Actos is the potential for a stronger link between the drug and disease. While studies showed that Avandia was linked with an increased risk of stroke and heart attacks, many other factors can cause, or contribute, to such trauma.

On the other hand, bladder cancer has a much more limited array of causes, which may help plaintiffs when making their case. Some predict the number of cases against Takeda may reach 10,000, as those currently filed are still working their way through pretrial consolidation. A number of preliminary issues remain to be settled in those cases, such as location and selection of the judge to hear the case.

Certainly, the most recent findings suggest that further evidence of a link may not be far away. While the drug is still available in the U.S., prescribers may want to consider alternative treatments for their patients to limit the risks of severe disease.

If you or someone you know has taken Actos for treatment of diabetes, contact an experienced personal injury attorney for legal advice and an evaluation of your situation.