France and Germany Suspended Use of Actos for Bladder Cancer Risk
In June 2011, Actos (Pioglitazone HCl), a leading diabetes medication globally, faced suspension in France and Germany over concerns of an increased bladder cancer risk. This action was prompted by a French epidemiological study's findings, revealing that long-term Actos users had a higher bladder cancer risk compared to those on other diabetes drugs.
Despite these findings, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) allowed sales to continue while further data review was underway. However, the FDA advised healthcare professionals against prescribing Actos to patients with active bladder cancer and urged caution for those with a history of the disease.
The study in question tracked about 1.5 million people from 2006 to 2009, noting a slightly elevated risk of bladder cancer, especially in men and in those with prolonged exposure to the medication or high cumulative doses.
It revealed that long-term Actos users had a 22% higher risk of developing bladder cancer. Notably, the risk jumped to 75% for those with the highest dosage and longest usage, particularly in men, who faced a 28% higher risk than women.
Following these results, France's health product safety agency first halted Actos sales on June 9, 2011. Germany's medical regulatory body quickly echoed this decision, advising against new Actos prescriptions pending further risk assessment.
Shortly after the European suspensions, the FDA, citing a five-year interim review from an ongoing ten-year study, warned that using Actos for over a year might heighten bladder cancer risk.
While not withdrawing Actos from the U.S. market, the FDA updated its safety information on it, indicating an association with an increased risk of bladder cancer for users with over a year of exposure. The agency also called for including these risks in the drug's labeling and patient guides, aiming to inform patients about potential bladder cancer risks.
Recent Update
In 2016, the FDA reaffirmed the risk of bladder cancer associated with the use of pioglitazone. This update followed a comprehensive review of data. Originally, concerns arose from a Kaiser Permanente study, but conflicting findings from a JAMA-published study called for further research. Recent studies in the UK, following patients for an average of 4.7 years, supported the initial findings linking pioglitazone to an increased risk of bladder cancer.
