Actos Bladder Cancer Risk Doubles Two Years Out

Montpellier, FRANCEThe downside of clinical research: you sometimes have to talk out of both sides of your mouth. Such is the case with the latest research surrounding Actos bladder cancer, which suggests that patients taking pioglitazone for more than two years face a doubled risk for bladder cancer.

In the same breath, they say in absolute terms that risk is low.

Actos and bladder cancer remains a concern, according to a recent report from Reuters Health (6/1/12). The study, conducted by Canadian researchers, scrutinized the records of more than 115,000 British patients "newly treated" with diabetes drugs. The research spanned a period of 21 years starting in 1988 and ending in 2009.

What the researchers found was that use of Actos for two years or more could be associated with 88 additional cases of Actos bladder cancer per 100,000 person years. For patients found to have taken in excess of 28,000 milligrams of Actos during their treatment history, that number rose to 137 additional cases per 100,000 person years.

The study was published online by the British Medical Journal (BMJ). "Prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone is still acceptable for their patients with diabetes," wrote Dominique Hillaire-Buys and Jean-Luc Faillie from the Department of Medical Pharmacology and Toxicology in Montpellier, France in an editorial accompanying the study.

They predicted the study would prompt renewed questions about future use of Actos.

Actos side effects are not limited to the potential for bladder cancer. Actos heart failure is another concern, although the latter is thought to carry less risk than that of Avandia, Actos' chief rival in the hotly competitive Type 2 diabetes market. When Avandia's fortunes plunged in tandem with the publication of studies damning Avandia for increased risk to the heart, Avandia manufacturer GlaxoSmithKline argued that Avandia heart risk was no worse than that of Actos.

Even though Actos did carry a risk for heart failure, doctors switched their Type 2 diabetes patients away from Avandia to Actos in droves, and sales spiked. Takeda Pharmaceuticals, the manufacturer of Actos, enjoyed sales of nearly $5 billion during the 12-month period ending in March 2010, according to Reuters.

Sales have since declined with the concern over Actos bladder cancer—and there are other Actos side effects that have been targeted in many an Actos lawsuit.

The potential for Actos macular edema is yet another concern, over and above Actos CHF (congestive heart failure) and Actos bladder cancer.

It is a touch ironic that while both Actos and Avandia have been linked to heart problems (with the allegation that Avandia is worse), Avandia has not been linked to bladder cancer.