Trenton, NJFollowing news that the US Food and Drug Administration (FDA) updated the warnings about Actos side effects come reports that the first lawsuits alleging Actos bladder cancer have been filed. Those lawsuits allege that there is a link between the use of Actos and bladder cancer, and that patients were not adequately warned about that risk.
According to The Washington Post (08/05/11), lawsuits have been filed against Takeda Pharmaceuticals Co. Ltd., maker of the Actos diabetes medication. The lawsuits were filed by patients who say they developed bladder cancer after using Actos to control their diabetes. The FDA recently issued a warning about Actos and bladder cancer, but has not pulled the medication from the market.
On August 4, 2011, the FDA announced that medications containing pioglitazone, the generic version of Actos, would carry a warning that use of those medications for more than a year may be associated with an increased risk of developing bladder cancer. At the time, the FDA noted that pioglitazone should not be used in patients with active bladder cancer and should only be used with caution in patients with a prior history of bladder cancer.
The warning was issued after the FDA reviewed data from a 10-year study on Actos. The FDA noted that although there was no overall increased risk of bladder cancer with pioglitazone use, "an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone (FDA, 06/15/11)."
As a result of studies in France, which suggested an increased risk of bladder cancer associated with the use of pioglitazone, France suspended use of the medication while Germany recommended not starting new patients on the drug.
Actos was expected to be a big seller after its rival drug, Avandia, had its uses limited by the FDA because of concerns about links to heart problems. GlaxoSmithKline, maker of Avandia, faced lawsuits alleging its drug caused patients to experience serious adverse heart events, including heart attack.
Now, the maker of Actos faces lawsuits alleging its product caused bladder cancer. As of the beginning of August, the first lawsuits against Takeda were reportedly filed. One such lawsuit was filed by Nancy Rios, who took Actos for more than 10 years and has had two surgeries to remove tumors from her bladder. She is one of potentially thousands of people who could face off against Takeda in court.
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