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A leading diabetes treatment drug, Actos, has been the subject of heightened interest recently due to its being implicated in an increased incidence of bladder cancer among patients taking the drug, the announcement of the launch of its generic counterparts, and a recent consolidation of federal lawsuits against its manufacturer.

Just within the past month, the generic version of Actos has been approved by the Federal Drug Administration. Mylan Pharmaceuticals Inc. announced its launch of the generic version of Actos and Actoplus Met. Teva Pharmaceuticals Industry has also gained approval to manufacture and market generic versions of Actos and Actoplus Met.

Pioglitazone, or Actos, is in a class of medications called thiazolidinediones. Actos is manufactured by the Japanese pharmaceutical company, Takeda Pharmaceutical Co. Ltd. Pioglitazone is used as an adjunct to diet and exercise to treat type 2 diabetes mellitus. The drug works by increasing a cell's sensitivity to insulin, thus enabling the body to uptake sugar from the blood into the cells.

While the mechanism by which piolglitazone causes an increase in bladder cancer is unknown, it has been postulated that an increased sensitivity to insulin may also be a factor in the increased risk of cancer because cancer cells are also affected by insulin. Other animal studies indicate that pioglitazone may cause development of crystals in the bladder — resulting in irritation which could be a factor in cancer development.

Recent studies have corroborated the link between Actos, or pioglitazone, and a heightened risk of developing bladder cancer. In two of the most recently reported studies, researchers at the University of Pennsylvania determined that patients who took Actos had an increased risk of bladder cancer. The incidence of bladder cancer rose as the length of time of the patients' usage of the drug increased. In July, 2012, a Canadian study by the University of Alberta School of Public Health reported a similar increase — by 22% — in the occurrence of bladder cancer among Actos users.

Because of the link between the use of Actos and bladder cancer, Consumer Reports has recommended that patients not take Actos, or it generic counterparts.

In July, 2012, Judge Rebecca F. Doherty set the schedule for bellwhether trials in which the subject of the litigation is the link between Actos and bladder cancer. Bellwhether trials are used when there is large number of lawsuits centering on a common cause or claim. It is a way for the courts to manage these actions, and give the parties a guide as to the course of future litigation. In scheduling the first trial for November, 2013, Judge Doherty is allowing for ample discovery time in the case of the federal Actos lawsuits.

Other drug combinations containing pioglitazone are Actomet Plus, Actomet Plus XR, and Duetact

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