Drug regulators in France and Germany have suspended the use of the diabetes drug pioglitazone – found in brand name drug Actos, manufactured by Takeda – in light of a recent study linking the drugs to an increased risk of bladder cancer. Pioglitazone is usually prescribed to treat Type 2 diabetes.
The ban comes in the wake of a French study conducted by the nation’s health insurance agency, which examined cancer rates in approximately 155,000 people taking pioglitazone in France from 2006 to 2009, and 1.3 million other diabetics who were not receiving the agent.
The European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA), as well as their counterpart agency in Japan, have not yet ruled on the drug, pending independent review of the data. The FDA began a review of pioglitazone and cancer risk last September, and the EMA has been reviewing the drug since March 2011. However, neither agency has yet issued a ruling on the drug.
In September 2010, the FDA issued a safety announcement suggesting a potential safety risk with Actos (pioglitazone). Although it concluded that there was no significant reason to remove the drug from use, the FDA reported in its data summary that “the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure.”
Doctors in France and Germany have been advised to stop prescribing pioglitazone (Actos) as well as another drug manufactured by Takeda, Competact, which combines pioglitazone with metformin.
Sources:
FDA
PharmaTimes
MedPage Today
