Actos Bladder Cancer Litigation Expected to be Massive

The diabetes drug <"">Actos is expected to be named in hundreds of lawsuits claiming it caused users to develop bladder cancer. According to a report from the Associated Press, Actos sales are also expected to take a big hit because of the bladder cancer controversy.

For now, at least, Actos is the best selling type 2 diabetes drug in the world. But in June, a study of more than 1 million diabetics – including 155,000 on Actos and 1.3 million on other medications – 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.

After the study was released, regulators in France and Germany pressured Takeda Pharmaceuticals to pull Actos from the markets in their countries. The study also prompted the U.S. Food and Drug Administration (FDA) and the European Medicines Agency to issue new bladder cancer warnings for Actos.

Last week, the first of what lawyers say will be thousands of Actos bladder cancer lawsuits was filed in the U.S., the Associated Press said. The plaintiff in that lawsuit is a 54-year-old Pennsylvania woman who developed recurrent bladder cancer after taking Actos for a decade.

Several lawyers told the Associated Press that they have 100 or more Actos bladder cancer cases pending at their firms.

All of this is bad news for Actos sales, the Associated Press said. Actos, despite being tied to other side effects such as heart problems, became popular because it does a good job of controlling blood sugar and allowed some patients to reduce their reliance on insulin. Another selling point was the fact that Actos only needs to be taken once per day. But already, patients and their doctors are considering other options.

“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, told the Associated Press.

Actos’ problems could also mean the end of the thiazolidinediones class of diabetes drugs, which has long been plagued by safety problems. Last year, sales of Avandia, another thiazolidinedione, were restricted by the FDA because of its association with heart problems. Another, Rezulin, was recalled in 2000 because of an association with liver problems.

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