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New Bladder Cancer Warning for Diabetes Drug Actos

actosOn June 15, 2011, the FDA announced that taking of Actos, a diabetes medication, for more than one year may be associated with an increased risk of bladder cancer.

The decision is based on a 10-year study where at the five-year point, results showed that although there was no overall increased risk of Actos bladder cancer, an increased risk of bladder cancer was noted among patients with the longest exposure to Actos as well as  the highest cumulative dose of Actos.

However the European version of the FDA took a more radical stance based on their own but similar study which also increased the risk of bladder cancer from taking Actos.  France suspended the use of Actos entirely and Germany has recommended not prescribing Actos for new patients.

The European Medical Agency or EMA for short plays an important role in the authorization of medicines that treat diabetes. In the European Union all medicines for diabetes must be authorized via the EMA, rather than each Member State doing their own thing.

The EMA works closely with organizations representing patients with diabetes through the Insulin Dependent Diabetes Trust and the International Diabetes Federation.

One has to wonder why a country like France stops using Actos diabetic drug and a country like the USA slaps a fine print warning label on it.

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