The US-FDA first released a safety announcement in September 2010 concerning Actos and bladder cancer. Based on the reviewed data of a five-year interim analysis, the agency informed that the risk of developing bladder cancer with Actos needs further research. However, according to the reviewed data, it was observed that patients with the longest exposure and the highest effective dose of Actos were at greater risk of developing bladder cancer.
After that, nearly nine months later based on the results of an epidemiological study, the Agency for the Safety of Health Products of France issued an Actos recall on June 9, 2011. The epidemiological study, which was conducted by the French National Health Insurance, found that patients, who were taking type 2 diabetes medication Actos for a long time, significantly increased risk of bladder cancer compared with patients who took other anti-diabetic drugs.
The French epidemiological study followed roughly 1.5 million patients around a period of three years between 2006 and 2009, and they found an adjusted hazard ratio of 1.22 for Actos bladder cancer risk. The results of the epidemiological study also showed hazard ratio for longest exposure and cumulative dose of the medication. The cumulative dose greater than 28,000 mg in Actos users illustrated an adjusted hazard ratio of 1.75, and a hazard ratio of 1.34 was found with the longest exposure (more than a year) of the drug.
After the press release from the French agency, just one day later the German Federal Institute for Drugs and Medical Devices declared to follow suit with the French epidemiological study on June 10, 2011. The German Federal Institute recommended physicians not to prescribe Actos in new patients.
Later in the same month, just days after the suspension from two European countries, the FDA issued another warning about Actos bladder cancer risk on June 15, 2011. This safety announcement informed public and healthcare professionals that the use of Actos for longer than 12 months might be linked with the increased risk of bladder cancer.
Before this announcement about Actos bladder cancer risk, the FDA reviewed data from a 5-year interim analysis of an ongoing study. The five-year interim analysis followed around 193,000 patients with type II diabetes, and the age of the studied patients were ≥ 40 years. The interim analysis showed that patients who were taking higher doses of Actos for longer than 12 months developed the risk of bladder cancer up to 40% compared to patients who never being exposed to Actos (HR [Hazard Ratio] 1.4, 95% CI [Confidence Interval] 0.9 to 2.1).
However, the FDA still allowed sales of Actos in the U.S. market, yet the agency suggested adding the warning of Actos bladder cancer risk in the labeling and patient medication guide.
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