Posted October 19, 2011 by Newsome
The U.S. Food and Drug Administration recently announced “that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” The FDA explains that from January 2010 through October 2010, “approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.”
The FDA also explains that the “patient Medication Guide for these medicines will be revised to include information on the risk of bladder cancer.” However, these safety measures may have come too late. Actos bladder cancer lawsuits have already been filed by dozens of individuals who claim Takeda pharmaceuticals, the maker of the drug, did not perform adequate research into their medication or properly warn about the associated risks.
One such lawsuit comes from a man who is suing the maker of this drug, claiming he “developed bladder cancer after taking medication to treat his type II diabetes,” the Madison Record explains. According to the article, Robert Bettorf began taking the medication in 2007 and was diagnosed with bladder cancer the following year. This suit states that “Takeda and Eli Lilly were aware as early as 2005 of the increased risk of cancer associated with the drug, but failed to warn consumers of it,” the Madison news source reports.
A June article published by ABC News explains that individuals “taking the diabetes drug Actos for more than a year may have an increased risk of bladder cancer, according to an FDA interim review of an ongoing epidemiological study.” That warning from the FDA came only days after two European nations banned this drug’s use, the news source reports.
ABC goes on to explain that despite five-year study data which shows “no overall increased risk of bladder cancer, patients with the longest exposure to and the highest cumulative dose of the drug were at greater risk.” This includes individuals like Robert Bettorf, the Madison Record explains, who continued taking the medication until 2011 because he was not aware of such risks.
However, ABC News reports that this is not the first medication in its class to be linked to serious side effects. According to that report, “Actos is now the second medication in the thiazolidinedione (TZD) class to be associated with serious side effects,” after Avandia’s use was “severely restricted in the U.S.” over concerns of a rise in heart attacks among its users. The news report explains that recent concerns over these medications may cause doctors to move away from prescribing medications in this class.
The most recent FDA safety announcement explains that healthcare professionals should avoid prescribing Actos for patients “with active bladder cancer,” as well as using caution “in patients with a prior history of bladder cancer.” The FDA explains that in its efforts to protect the public from the potentially lethal side effects of this medication, it will continue evaluating data from the ten-year ongoing study, review other study results, and release public updates as soon as they become available.
