The European Medicines Agency (EMA) will allow Actos, to remain on the market in Europe, with more serious warnings regarding potential bladder cancer risks. Actos is Takeda Pharmaceutical’s controversial Type 2 diabetes drug. A report from the EMA’s Committee for Medicinal Products for Human Use determined that the benefits of piolglitazone, the active ingredient in Actos outweigh its risks in some Type 2 diabetes patents.
“These medicines remain a valid treatment option for certain patients with Type 2 diabetes,” said the agency, while still acknowledging the increased bladder cancer risk. The EMA further stated that the risk could be minimized with “appropriate patient selection and exclusion,” such as drug reviews in individual patients.
Takeda’s Actos troubles began in June 2011, after a study by the French government found that Actos patients face a higher risk of bladder related cancer compared to those treated with other diabetes medications. The French study examined the cancer rates in 155,000 patients taking Actos in France from 2006 to 2009 as well as 1.3 million other diabetics on other treatments. The study determined that patients taking Actos had about a 22 percent higher risk of bladder cancer. The risk of developing bladder cancer was highest in those patients receiving a cumulative dosage of Actos at 28,000 mg or more during the study period.
The study resulted in the French government banning the sale of Actos and other drugs containing piolglitazone. The French study also prompted Germany’s drug regulator to suspend sale of Actos in that country.