Wednesday, May 16, 2012

FDA Approves Cancer Warning for Diabetic Drug Actos

The blockbuster drug, Actos, which is prescribed to control Type 2 diabetes, has received new warning language on the label regarding a potential risk of bladder cancer for those taking the drug. Actos, also known as pioglitazone, is manufactured by Takeda Pharmaceuticals, a Japanese-based company, and is currently their best-selling drug, with sales of $3.4 billion last year alone. Sales of Actos had shown a significant upswing due to the fact that its primary competitor—Avandia—has been linked to a higher risk of heart attack and even death. The updated label warnings came on the heels of an EMA safety review of the drug as well as a ten-year study conducted by Takeda. The Takeda study indicated a statistically significant increase in the risk of bladder cancer for those taking the drug for longer than two years.

Other Drugs Containing Pioglitazone
Other than Actos, the drugs ActoPlus Met, ActoPlus Met XR and Duetact will all carry the same warnings due to containing pioglitazone as an active ingredient. All of these drugs are used to treat Type 2 diabetes, to increase sensitivity to insulin and effectively control blood sugar levels. A combination drug containing metformin and pioglitazone is used for the same purpose, although all these drugs are expected to be used in conjunction with a healthy diet and sensible exercise program.

France and Germany Weigh In
Just this past June, both France and Germany issued recalls of Actos following a public insurance data review which showed a fairly strong correlation between pioglitazone and bladder cancer risk. Suggestions from the EMA study related primarily to including more cautionary warnings on the labels of the drug as well as a six-month review of each patient taking Actos.

Additional Cautions
Additionally, the EMA advised physicians to practice more appropriate patient selections as well as exclusions for specific groups when considering the drug. Specifically, those patients who have bladder cancer or have had the disease in the past should be prescribed an alternative drug as should the elderly. All patients who take Actos should have regular checkups and appropriate medical tests performed regularly to address safety concerns.

First Lawsuit Filed
A California man who developed an aggressive form of bladder cancer after taking the drug for two years has filed the first lawsuit against Takeda, however it is expected that many more complaints are forthcoming. Throughout the United States Actos lawyers will be investigating and evaluating potential cases for those who feel their health was negatively impacted through the use of Actos.

Author: Sullo & Sullo Attorneys

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