October 15, 2012 — The Institute for Safe Medication Practices (ISMP), a non-profit consumer advocacy group, has reviewed the U.S. Food and Drug Administration (FDA) database of adverse events and published a QuarterWatch report.
Since 2011, they identified 1,025 reports of bladder cancer in which Actos (pioglitazone) was the primary suspect — including 235 new cases in the first quarter of 2012 alone. This “surge of reports” highlights the “extremely slow and uncertain process through which the cancer risks of prescription drugs are identified and their significance assessed.”
The risk of Actos bladder cancer was first identified 13 years ago, in 1999. Takeda Pharmaceuticals conducted animal studies where rats and mice were given high doses of Actos. The rats could only tolerate doses about 7-times the normal human dose. The rats had an increased risk of bladder cancer, possibly due to calcium nodules that formed. When the FDA approved Actos, they required warnings about a possible increased risk of urinary bladder cancer. The FDA also required Takeda to conduct a 10-year safety study.
In 2010, Actos was the most frequently prescribed medication for controlling type-2 diabetes. However, the popularity of Actos decreased dramatically after studies linked the drug to an increased risk of bladder cancer. Preliminary results from the 10-year study identified an increased risk of bladder cancer among people who had used Actos for at least 24 months. French researchers also found an increased risk of bladder cancer, which led French and German health authorities to suspend sales of the drug. Actos remains on the market in the U.S., but prescriptions have dropped 38% to 1.8 million in the first quarter of 2012.
The ISMP wrote that the “surge of reports” could be due to a “feedback loop.” As more people become aware of the link between Actos and bladder cancer, there is a greater chance that these illnesses will be reported. Researchers, regulators, physicians, and law firms all increase public awareness about drug side effects when risks are identified. Although ambiguity remains in the data, the adverse events are an important signal when evaluating cancer risks from prescription drugs.
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