Despite Bladder Cancer Risk, Actos Still Valid Treatment: European Comm.
European health officials have determined that Actos is still a valid treatment for diabetes, despite serious concerns about the potential risk of bladder cancer from Actos.
A recent decision by the European Commission backs the findings of the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP), which last summer ruled against an Actos recall.
The decision contradicts the determinations of two of the European Union’s most powerful member states; France and Germany. Those two countries pulled Actos from shelves following a French study conducted by insurance companies which found that Actos side effects increased the risk of bladder cancer.
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The European Commission’s ruling means that a stronger label warning and more intense patient screening is all Actos will face in Europe outside of France and Germany.
Actos (pioglitazone) was approved by the FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. The medication has grown in popularity in recent years, generating $4.3 billion in sales last year.
In the United States, FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug.
Over the past year, a growing number of Actos bladder cancer lawsuits have been filed against Takeda Pharmaceuticals, the manufacturer, alleging that the drug maker concealed their knowledge that users may face an increased risk of bladder cancer and failed to provide adequate warnings to patients and the medical community.
All Actos lawsuits filed in federal courts throughout the United States have been consolidated and centralized in the U.S. District Court for the Western District of Louisiana as part of an MDL, or multidistrict litigation.
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