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France and Germany Pull Actos off the Market Due to Bladder Cancer Risk, FDA Still Reviewing

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June 10, 2011

Regulators in France and Germany yesterday pulled Actos (pioglitazone), the most widely used medication for the treatment of type 2 diabetes, off the market after a study sponsored by the French government found it increased risk of bladder cancer.

The French study followed 155,000 people taking pioglitazone and 1.3 million diabetics who did not between 2006 and 2009. Results showed people taking the drug had increased risk of bladder cancer and that the risk was greater in those on a higher dose or who had higher cumulative dosages.

Actos (pioglitazone), made by the Takeda Pharmaceutical Company, is in a class of medications called thiazolidinediones. The only other drug in this class is GlaxoSmithKline’s Avandia (rosiglitazone), which the FDA has severely restricted because it increases risk of heart attack.

Actos is still available in the U.S. The New York Times reports that Actos sales in the United States were $3.4 billion in 2009.

In September 2010, the U.S. Food and Drug Administration (FDA) announced the agency was reviewing data from the first five years of a ten-year study conducted by the manufacturer.

“These early results showed no overall association between Actos exposure and risk of bladder cancer,” the FDA said in 2010. “However, there was 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.”

Takeda tells CBS News that the FDA has not given any indication of a recall.