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France, Germany Halt Sales of Diabetes Drug Actos Due to Cancer Link


The antidiabetes drug Actos (pioglitazone) will be pulled from the retail market in France and Germany after a report by The French Agency for the Safety of Health Products (AFSSAPS) that links 47 cases of bladder cancer in patients taking the drug. Other European countries are considering action, and last September, the US Food and Drug Administration launched an investigation using preliminary evidence from an ongoing Kaiser Permanente study.

Pioglitazone Linked to Increased Risk of Bladder Cancer, Fractures

Pioglitazone is marketed by Takeda Pharmacuetical Co Ltd. The drug belongs to a class of medications known as thiazolidinediones and works by reducing insulin resistance. In addition to the brand well known to Americans – Actos – the drug is also used in Europe in a medication known as Competact which combines pioglitazone with metformin.

Read: Preliminary Evidence Links Diabetes Drug Actos to Bladder Cancer

The French Medicines Agency pulled Actos from the market Thursday after the findings of a major study, conducted by the National Health Insurance (CNAM. The study involved about 155,000 people taking pioglitazone in France from 2006 to 2009. Those taking the drug had a greater risk of bladder cancer than those in a control group, and those with higher doses (cumulative dosage of 28,000 milligrams or more during the study period) had a greater risk.

Jean-Louis Montastruc, a professor of pharmacology in Paris, said “This drug is lethal in the short term, causing cancers of the bladder. In addition, it increases the risk of fracture. I have nothing against the laboratory that manufactures it, but I say this in the interest of patients.”

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While physicians are not allowed to prescribe Actos or Competact to new patients, those who are on the drugs currently should continue to take them until they consult with their doctors.

Read: Study Finds Avandia and Actos to have Same Cardiovascular Risks

Other European countries are also considering action based on the findings. A spokesperson for the European Medicines Agency said that experts will discuss the drug at an upcoming meeting to be held later this month. The agency had initiated its own review of Actos in March.

Both Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the Danish Medicines Agency reported watching the situation closely, but were not recommending changes at this time. Japan, home to Takeda, has also weighed in, saying they had no plans as of yet to halt sales of the drug.

Read: FDA Further Restricts Retail Sales of Diabetes Drug Avandia

Robert Spanheimer, Takeda’s Vice President of Medical and Scientific Affairs, has told Reuters Health that the company had not yet had time to review the French study, but did note that “The FDA has had a look at all our data and have not given us an indication at this time.”

Actos was approved in 1999 in the US and in 2000 in Europe and is Takeda Pharmaceuticals top-selling medication, with global sales of $4.8 billion in the last financial year. Since significant restrictions were recently placed on its competitive medicine, Avandia from GlaxoSmithKline, physicians have been switching patients over to Actos when appropriate.