Actos Named in another Bladder Cancer Lawsuit

More <"">Actos lawsuits are being filed by people who claim the type 2 diabetes drug caused them to develop bladder cancer. The most recent Actos bladder cancer lawsuit, filed in federal court in San Francisco, alleges Takeda Pharmaceuticals failed to warn patients about the bladder cancer risk associated with Actos.

Actos is expected to be named in hundreds of lawsuits claiming it caused users to develop bladder cancer. Earlier this moth, several lawyers told the Associated Press that they have 100 or more Actos bladder cancer cases pending at their firms. More than 20 firms, from Florida to Washington state, are advertising for clients on the Internet or in newspapers, the report said.

The U.S. Food & Drug Administration (FDA) mandated in June that new information regarding bladder cancer be added to the “Warnings and Precautions” section of the Actos label. The FDA acted 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 new Actos 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. 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.

That same month, regulators in France and Germany suspended sales of Actos after a separate study indicated those taking Actos were more likely to develop bladder cancer. That study, commissioned by the French government, involved 1 million patients and 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.

The European Medicines Agency has also called for new bladder cancer warnings for Actos. Its recommendations include a six month review for every patient taking Actos. A statement from the agency also said Actos bladder cancer risks may be reduced by appropriate patient selection and exclusion.

Actos was approved by the FDA to treat Type 2 Diabetes in July, 1999. It became the best-selling type-2 diabetes drug in the world after Avandia, its main competitor, was linked to heart problems in 2007.

In addition to bladder cancer, Actos has also been associated with heart problems and other serious side effects. In June, for example, a study presented at the American Diabetes Association’s annual meeting in San Diego reported that people taking Actos, as well as Avandia, are 3 to 6 more times likely to develop diabetic macular edema, an eye condition that can lead to blindness.

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