Categorized | Bladder Cancer

Pioglitazone (Actos) Drug Suspended in France and Germany Due to Possible Bladder Cancer Link

Diabetes drug Actos (pioglitazone), sold by Takeda Pharmaceutical’s have been suspended in France and Germany because of its potential bladder cancer risk which was seen in tests of male rats.

Actos was approved for use in Europe in 2000.

In France, after an official French study found that the drug appeared to slightly raise the risk of bladder cancer, France’s drug safety authority suspended the use of Actos. In addition it also suspended the use of Competact which combines the use of pioglitazone and metformin.

Germany followed suit after receiving results of the study by France’s national health insurance body which tracked patients on diabetes drug between 2006 and 2009.

Both the French and German regulators said patients currently being prescribed Actos should continue to take their medications until they could consult with their doctors.

A spokewoman for European Medicines Agency said it wasn’t aware of any other national authorities taking action.

Britain’s drugs regulator said it was not recommending any changes to Actos use while the European review was going on and the Danish medicines agency also had no plans on suspending the drug.

In the United States, FDA initiated a safety review of Actos last September but Takeda said U.S. regulators had not signaled any intention to request a recall.

GlaxoSmithKline’s Avandia (rosiglitazone) which belongs to the same drug class as Actos was pulled from the market in Europe and had severe restrictions imposed on its use in the United States last September after being linked to heart risks.  Avandia has not been associated with bladder cancer.

U.S. health insurer Kaiser Permanente conducted trials in 2003 and is slated to last 10 years have so far not confirmed a clear association between Actos and bladder cancer.

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