On June 09, 2011, the French Medicines Agency (Afssaps) announced that based on an independent database study among patients using Actos (pioglitazone hydrochloride), that there is a connection between using the diabetes drug Actos and bladder cancer. As a result of these findings, the French agency suspended the use of the drug Actos. Doctors in France can no longer prescribe Actos to their new patients. Also, patients that are currently using Actos have been advised to speak with their physicians about adapting their diabetes treatment. A day after these finding were released, Germany also suspended use of Actos.
22% increase Study Show For Actos And Bladder Cancer
The independent database study of 155,000 diabetic patients that had taken the drug Actos found a 22% increase in bladder cancer. There was roughly a 50% increase in Actos and bladder cancer among those patients using a higher dosage of Actos compared to those who had taken a lower dosage.
Takeda Pharmaceutical Company Limited based in Osaka, Japan, is the manufacturer of the diabetes drug Actos and Asia’s largest drug manufacturer. During fiscal year 2010, Actos, which is Takeda’s best-selling drug for diabetics, accounted for 51.8% of their U.S. sales and $4.3 billion in global sales. Over 25 million Americans are affected by type 2 diabetes, which is the most common form of diabetes. Actos has been widely used in the United States with almost 2.3 million diabetics having filled a prescription for Actos or a drug containing pioglitazone in 2010.
FDA Reacts to French Study
One week after the 2011 French study, the U.S. Food and Drug Administration (FDA) weighed in by stating that the risk of Actos and bladder cancer may increase among those diabetics that used Actos for one year or longer. The FDA ordered that U.S. labeling be updated with a “black box warning” against using Actos if the patient has a history of bladder cancer. The black box warning also includes information about the connection between Actos and bladder cancer. The FDA is more than five years into a ten-year study about Actos and bladder cancer. The data thus far shows a greater likelihood of Actos and bladder cancer in diabetics that have taken the drug for over one year and for those that have taken higher dosages. These findings are very similar to the previous French study findings.
On a side note, the FDA announced on November 18, 2011 that it is delaying review of a developmental compound drug which will include Actos. This new diabetes drug is also manufactured by Takeda Pharmaceutical Company Limited.a
What Is Actos And Bladder Cancer?
According to the National Cancer Institute, bladder cancer forms in the tissues of the bladder which is the organ that stores urine. Bladder cancer usually starts from the cells that line the bladder, also known as transitional cells.
It is estimated that there will be 73,510 new cases of bladder cancer and 14,880 deaths from bladder cancer in the United States in 2012.
Symptoms of may include:
- Finding blood in your urine (which may make the urine look rusty or darker red)
- Feeling an urgent need to empty your bladder
- Having to empty your bladder more often than you used to
- Feeling the need to empty your bladder without results
- Needing to strain (bear down) when you empty your bladder
- Feeling pain when you empty your bladder
Some diabetics will find themselves facing the diagnosis of Actos and bladder cancer. While it can be difficult to pinpoint what exactly causes any cancer to occur in a specific patient, it is known that cancer may be a result of chemical exposures, cigarette smoking, radiation and chemotherapy, and even unsafe drugs—such as Actos.
Actos and Bladder Cancer Lawsuit
Diabetic patients who are currently prescribed Actos or who have taken it for long periods of time in the past deserve to understand the risks associated with their treatment—including the possibility that Actos will increase the likelihood of bladder cancer. If you or a loved one received an Actos bladder cancer diagnosis, you may have legal recourse.
The plaintiffs filing Actos lawsuits claim that Takeda withheld information about the risk of bladder cancer and failed to provide adequate warnings to consumers. Due to evidence confirming the link between Actos and bladder cancer, an Actos recall was issued in France and Germany. An Actos recall has not been issued in the United States.
Several thousand patients have contacted plaintiffs lawyers about filing such suits, Paul J. Pennock, a New York-based lawyer representing former users of the drug, said in an interview last month.
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