New FDA Actos Bladder Cancer Warning Debuts

The U.S. Food & Drug Administration (FDA) has approved a new label warning for <"">Actos (pioglitazone) regarding its association with bladder cancer. The new label advises that health care professionals avoid using Actos in patients with active bladder cancer and recommends caution in patients with a prior history of bladder cancer.

The new bladder cancer information will be included in the ‘Warnings and Precautions” section of the drugs’ label. Actos patients are encouraged to contact their health care provider if they notice any sign of blood in the urine, any new or worsening urinary urgency or pain during urination.

The new warnings has also been added to the labels of Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended release), and Duetact (pioglitazone/glimepiride).

The FDA announced the new Actos bladder cancer warning in June, after interim data from a review of 193,099 diabetics revealed that those taking the drug for more than a year had a 40 percent increased risk for bladder cancer. The 10 year study on which the new warnings are based will be completed in 2012.

The FDA’s announcement came just days after regulators in France and Germany suspended Actos sales. Those decisions were made after a study of more than 1 million diabetics – including 155,000 on Actos and 1.3 million on other medications – that was commissioned by the French government found that Actos patients faced nearly a 22 percent higher risk of bladder cancer compared to those taking other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.

At the time, the FDA said it would conduct a comprehensive review of the results from the French study, and continue to evaluate data from the 10-year study. The agency said it would update the public when more information becomes available.

For now, at least, Actos is the best selling type 2 diabetes drug in the world. But it may not remain that way for long, thanks to its association with heart side effects, and now bladder cancer.

“The consensus already is that (Actos) should only be considered … after patients have exhausted all other options,” Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, recently told the Associated Press.

At least two Actos bladder cancer lawsuits have already been filed in the U.S., and plaintiffs’ attorneys told the Associated Press that hundreds more are waiting to be filed.

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