U.K. Drug Regulator to Discuss Actos – Bladder Cancer Worries

Regulators in the United Kingdom (U.K.) will meet this week to discuss <"http://www.yourlawyer.com/topics/overview/actos">Actos (pioglitazone), following release of a study that found patients taking the diabetes medication faced a higher risk of developing bladder cancer. Just last week, regulators in France and Germany suspended sales of Actos in those countries because of bladder cancer fears.

According to a report on FT.com, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) will meet Thursday, and Friday if needed, to discuss Actos. An unnamed source told FT.com” “It is a real issue. I think pioglitazone does cause a problem with bladder cancer, probably growth promotion.”

FT.com continued:

“The source explained that this because pioglitazone stimulates the peroxisome proliferator-activated receptor (P-PAR) gamma and alpha receptors and this bladder growth promotion is a class property of alpha/gamma agonists in rodents.”

On June 20, the European regulator, the Committee for Medicinal Products for Human Use (CHMP), will also meet to assess the Actos bladder cancer issue, FT.com said.

Last week, France’s drug regulator, Afssaps, directed doctors not to prescribe Actos after a study commissioned by the French government found a higher risk of bladder cancer among Actos patients. The directive also applied to another drug, Competact, which combines Actos and an older drug called metformin.

Shortly after receiving the report from French regulators, Germany’s Federal Institute for Drugs and Medical Devices (BfArM) followed suit.

The French study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the drug. The study found about a 22 percent higher risk of bladder cancer in those taking Actos compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.

In the U.S., Takeda Pharmaceuticals says the Food & Drug Administration (FDA) has not signaled any intention to request an Actos recall, according to a Reuters report. However, the FDA did begin an Actos safety review in September 2010 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.

In May, we reported that a new review of Adverse Event reports submitted to the FDA had suggested a “disproportionate risk” of bladder cancer associated with Actos compared to other diabetes drugs. The five-year review (2004-2009) looked at half million reactions to various diabetes medications, including 138 in which people developed bladder cancer. A fifth of those occurred in Actos patients.

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