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.
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