After a French study revealed an increased bladder cancer risk among diabetics using medicines containing Actos (pioglitazone) for more than 12 months, the French government suspended the use of these drugs on June 6, 2011.
Although the bladder cancer risk was slight, France's drug agency said the "risk-benefits ratio was now unfavorable" for Actos. Patients were told to consult their doctors for alternative treatment before stopping their Actos-containing medicines.
According to a government press release, 230,000 French patients had used these drugs since Actos was approved by itself in 2000 and in combination with metformin in 2006.
The French study involved a historical look at the medical records of 1.5 million French patients with type 2 diabetes from 2006 to 2009 as well as data from the early testing of the Actos side effects on animals and people.
Results found a 34 percent increased bladder cancer risk among patients who had taken the highest doses for more than a year. Men were more adversely affected than women.
Actos Use Allowed, But Limited, Across Europe
Upon the French suspension of Actos, Germany prohibited physicians from prescribing Actos-containing drugs to new patients.
And initially, the London-based European Medicines Agency, which reviews drug safety for the 27-country European Union, withheld action against Actos, pending the conclusion of its own European-wide investigation.
Since March 16, 2011, the EMA's Committee for Medicinal Products for Human Use had been reviewing clinical and pharmacological studies of Actos, published studies and ongoing post-marketing studies by Actos manufacturer Takeda Pharmaceuticals.
On July 6, 2011, the committee confirmed a small bladder cancer risk among patients using drugs containing Actos and issued new guidelines allowing their use as a last resort for patients whose diabetes could not be treated with other drugs like metformin.
The committee recommended that doctors monitor patients taking the drugs for three to six months to ensure Actos adequately controlled their diabetes. If not, patients should be removed from the medication because of the risks.
The American Food and Drug Administration would be the next agency to act.