This suspension was based on the results of an epidemiological study conducted by the French National Health Insurance. According to the results of the epidemiological study, the French agency found that patients, who were taking Actos for a long time to aid in type 2 diabetes mellitus, significantly increased risk of bladder cancer compared with patients who were taking other diabetes medications.
The regulators of both two European countries also suggested that patients who were prescribed Actos should continue taking the drug until their physicians recommends other alternative drug, because sudden stop of treatment could be dangerous for their health.
On the other hand, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) still permitted the manufacturer to continue sales of the medication until further review of data about Actos bladder cancer risk completed. However, the FDA informed healthcare professionals to stop prescribing Actos in patients who already have active bladder cancer, and exercise caution in patients with previous record of bladder cancer.
The French epidemiological study followed approximately 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 bladder cancer risk. The results of this study also illustrated hazard ratio for cumulative dose and longest exposure with the drug. An adjusted hazard ratio of 1.75 was found in patients with the cumulative dose greater than 28,000 mg, and patients with longest exposure (more than a year) of the drug showed a hazard ratio of 1.34. However, the study indicated a significantly increased bladder cancer risk in males (Hazard Ratio [HR] 1.28) compared with females.
Following the results of the study, the Agency for the Safety of Health Products of France first suspended sales of Actos in their market on June 9, 2011. After the announcement of AFSSAPS, on June 10, 2011, the Federal Institute for Drugs and Medical Devices of Germany announced to follow suit with the results of the French study. The German federal agency recommended that physicians should not prescribe Actos to the new patients until further clarification about Actos bladder cancer risk released.
Shortly after the suspension from the two giant European country, on 15th June 2011, based on the data of a five-year short-term analysis from a planned ongoing ten-year epidemiological study, the US-FDA informed public and healthcare professionals that the use of Actos for longer than 12 months might increase the risk of bladder cancer in patients.
Although, the US-FDA didn’t ban Actos from the U.S. market, but the agency recommended addition of the Actos bladder cancer risk in the labeling and patient medication guide of Actos. Nevertheless, this information will warn patients about the possible risk of developing bladder cancer with the drug.
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