French, Germans Pull Actos Over Bladder Cancer Concerns

A number of studies have linked bladder cancer with the diabetes drug <"">Actos (generic: pioglitazone), which is manufactured by Takeda Pharmaceutical Company. In response to concerns that the drug’s risks outweigh its benefits, Actos will be pulled from the French market, said Bloomberg News.

According to France’s drug regulator, Afssaps, a new study indicated that Actos carried an increased risk for bladder cancer, wrote Bloomberg News. Afssaps warns that while physicians should stop prescribing the drug, patients should not stop taking their medications without first speaking to their physicians. The regulator-commissioned study stated that the research “confirms a slight increase in the risk of bladder cancer in patients treated with pioglitazone,” quoted Bloomberg News.

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

“BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone,” the regulator said in a statement according to Reuters.

Actos was approved in Europe in 2000 as an option for diabetes patients not seeing a benefit from the more traditional metformin and insulin treatments, said Bloomberg, which noted that about 230,000 patients in France take Actos, according to Afssaps. Actos was approved in 1999 to improve glycemic control in adults with Type 2 Diabetes. The drug, which is in a class of medications known as thiazolidinediones (TZD), works by reducing insulin resistance. It belongs to the same class of drugs as Avandia, a diabetes medication that has been linked to an increased risk of heart attack and stroke.

The European Medicines Agency, which initiated its review of potential Actos-bladder cancer risks in March, said it will look at the French study; its Committee for Medicinal Products for Human Use plan on discussing the matter at its next meeting scheduled later this month. In the meantime, said Bloomberg News, the agency did not recommend any changes while the review is underway.

We recently wrote that another study found evidence that Actos may be associated with an increased risk of bladder cancer. According to a prior Reuters report, the study, which involved a review of adverse events reported to the US Food and Drug Administration (FDA) database, suggested a “disproportionate risk” of bladder cancer associated with Actos, in comparison with other anti-diabetics.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the US, according to the FDA. The rate of occurrence is thought to be higher in diabetics.

That new, five-year study (2004-2009) looked at half million reactions to various diabetes medications; 138 people developed bladder cancer; one-fifth occurred in Actos patients. “Disproportion is indicative of possible risk,” study author Dr. Elisabetta Poluzzi of the University of Bologna in Italy told Reuters, “not of an actual risk.” She said her study’s findings indicated that the Actos-bladder cancer issues warrants further study.

The label for Actos already contains information about bladder cancer risk its “Precautions–-Carcinogenesis, Mutagenesis, Impairment of Fertility” section. Studies in animals prior to the marketing of Actos showed an increase in bladder tumors in male rats exposed to the levels used in humans. Also, last September, we reported that the FDA had decided to begin a safety review of Actos after preliminary results of a study indicated an increased risk of bladder cancer. According to the agency, that study showed an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.

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