Actos Bladder Cancer Warning Sought by European Regulators

The European Medicines Agency (EMA) appears willing to allow <"">Actos, Takeda Pharmaceutical’s controversial diabetes drug, to remain on the market in Europe, though with new, more serious warnings regarding a potential bladder cancer risk. According to a report from SF Gate, the EMA’s Committee for Medicinal Products for Human Use has determined that the benefits of piolglitazone —Actos’ active ingredient—outweigh its risks in some patients diagnosed with Type 2 diabetes.

“These medicines remain a valid treatment option for certain patients with type 2 diabetes,” said the agency, while noting the increased bladder cancer risk. That risk, said the agency, could be minimized with “appropriate patient selection and exclusion,” such as ongoing drug reviews in individual patients, EMA said.

Takeda’s Actos troubles began last month, after a study commissioned by the French government indicated that Actos patients face a higher risk of developing bladder cancer compared to those treated with other diabetes medications. That study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics on other treatments. The study found about a 22 percent higher risk of bladder cancer in those taking Actos. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.

The study prompted the French to ban sales of Actos and other dugs containing piolglitazone, and Takeda has officially begun withdrawing Actos from the market there. The French Actos study also caused Germany’s drug regulator to suspend sales of the medication in that country.

Medications containing piolglitazone have been reviewed by the EMA over the past several months, said the SF Gate. Last year, the U.S. Food & Drug Administration (FDA) also began its own Actos safety review after an analysis of a decade-long study found an increased risk of bladder cancer among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos. Overall, however, the study did not show a statistically significant association between Actos exposure and bladder cancer risk, the agency said. The EMA’s new ruling supports the FDA’s finding.

Actos is part of a class of drugs called thiazolidinediones (TZDs), which have been linked to a number of serious side effects. This class also includes GlaxoSmithKline Plc’s Avandia, which has been associated with increased heart risks. Avandia’s heart problems prompted the EMA to suspend sales of the drug in September, while the FDA added new warnings to its label and placed significant restrictions on its sale. According to SF GATE, the TZD class also includes Warner-Lambert Co.’s Rezulin, which was recalled in 2000 over liver cancer and sudden death risks.

TZDs have also been associated with fluid retention, weight gain, and bone loss, in addition to heart risks, said SF Gate.

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