While the risk is very low; taking a certain prescription drugs, genericly known as Pioglitazone, for two years or more may double the risk of bladder cancer. From September 1999 to September 2011 the FDA received 121,715 reports of reactions related to the use of this drug. Researchers learned the risk increased as the cumulative dosage increased. (Source 2).
The study was funded by the Canadian Institutes of Health Research and the Canadian Foundation for Innovation. In the study, data was collected for almost 116,000 patients who were treated for diabetes for a period of 21 years. During a 5-year follow-up, 470 patients were diagnosed with bladder cancer. Not all these patients took Pioglitazone for diabetes. However, among the patients who did, there was an 83 percent increase in the relative risk of bladder cancer. In a broad spectrum of the United Kingdom population, the rate of cancer for older adults is 73 cases per 100,000.
Putting the Pioglitazone bladder cancer rate into perspective, the absolute risk was low with 89 cases among 100,000 people who took the drug during the five follow-up years. (Source 1).
While the Pioglitazone cancer risk is considered low, in June 2011, there was enough of a risk for the U.S. Food & Drug Administration to inform the public that using Pioglitazone for more than one year may be associated with an increased risk of bladder cancer. This information was to be added to the Warnings and Precautions section of the label for many name brand Pioglitazone drugs. The patient Medication Guide for the above medicines was also to include information on bladder cancer risk.
The FDA based their recommendation to inform the public further on data from a planned five-year interim analysis of an ongoing, 10-year epidemiological study. The 5-year results demonstrated that although there was no overall increased risk of Pioglitazone bladder cancer there was an increased risk of bladder cancer noted among patients with the longest exposure to Pioglitazone medication and for those patients exposed to the highest cumulative doses.
Concurrently, France was conducting its own epidemiological study for Pioglitazone medications and based on their findings, suspended the sale and use of Pioglitazone medications. Germany made the recommendation to not prescribe Pioglitazone to new type 2 diabetes patients.
Pioglitazone is indeed under the microscope and as always patients and doctors must dialogue about risks vs. benefits. Gone are the days, when doctors spoke and patients silently obeyed especially when there are safer, less expensive type 2 diabetes drugs in the marketplace and many opportunities to learn about drug safety and drug controversy.
Sources: (1) BMJ 2012, (2) See FDA-Reports.com: Adverse Event Data
The study was funded by the Canadian Institutes of Health Research and the Canadian Foundation for Innovation. In the study, data was collected for almost 116,000 patients who were treated for diabetes for a period of 21 years. During a 5-year follow-up, 470 patients were diagnosed with bladder cancer. Not all these patients took Pioglitazone for diabetes. However, among the patients who did, there was an 83 percent increase in the relative risk of bladder cancer. In a broad spectrum of the United Kingdom population, the rate of cancer for older adults is 73 cases per 100,000.
Putting the Pioglitazone bladder cancer rate into perspective, the absolute risk was low with 89 cases among 100,000 people who took the drug during the five follow-up years. (Source 1).
While the Pioglitazone cancer risk is considered low, in June 2011, there was enough of a risk for the U.S. Food & Drug Administration to inform the public that using Pioglitazone for more than one year may be associated with an increased risk of bladder cancer. This information was to be added to the Warnings and Precautions section of the label for many name brand Pioglitazone drugs. The patient Medication Guide for the above medicines was also to include information on bladder cancer risk.
The FDA based their recommendation to inform the public further on data from a planned five-year interim analysis of an ongoing, 10-year epidemiological study. The 5-year results demonstrated that although there was no overall increased risk of Pioglitazone bladder cancer there was an increased risk of bladder cancer noted among patients with the longest exposure to Pioglitazone medication and for those patients exposed to the highest cumulative doses.
Concurrently, France was conducting its own epidemiological study for Pioglitazone medications and based on their findings, suspended the sale and use of Pioglitazone medications. Germany made the recommendation to not prescribe Pioglitazone to new type 2 diabetes patients.
Pioglitazone is indeed under the microscope and as always patients and doctors must dialogue about risks vs. benefits. Gone are the days, when doctors spoke and patients silently obeyed especially when there are safer, less expensive type 2 diabetes drugs in the marketplace and many opportunities to learn about drug safety and drug controversy.
Sources: (1) BMJ 2012, (2) See FDA-Reports.com: Adverse Event Data
Michael Monheit, Esq. is a "Philadelphia Attorney" licensed to practice in Pennsylvania. A graduate of the University of Pennsylvania Wharton School of Business and Temple University Law School, he is the founder of Pennsylvania Law Firm Monheit Law.
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