European Drug Regulator Calling For New Warnings on Actos

A Reuters report was released this past week claiming that the European Medicines Agency (EMA) is stressing new warnings that link Actos to bladder cancer. The diabetes drug is said to have less of a negative impact with greater focus on patient selection.

Actos, which is developed by Japanese company Takeda Pharmaceutical, will likely carry warnings issued from the European Union because of this link to bladder cancer. The results were reported to come after a safety review conducted by the European drug regulator.

The EMA had a specialized committee (The CHMP, or Committee for Medicinal Products for Human Use) who was responsible for reviewing the issues with Actos. In their findings, they stated that the benefits of the drug for some diabetics may still outweigh the potential for risk. The future warnings could include a multiple month review of the performance of each drug on individual patients. The CHMP is said to be continuing research on Actos to find specifically if the risk is affected by determining factors such as age and duration of use.

This decision comes after last month’s choice from France and Germany to suspend the use of Actos and a similar drug. French researchers found a link to an increased risk of bladder cancer in the process, resulting in a recall of the drug.

The story states that the U.S .FDA recently released a statement on Actos, saying that it would soon add information relating to the potential risk of bladder cancer after long term use. This came following the results of the FDA safety review last September; they also claimed that the drug would continue to remain on the market for now.

Actos was approved as a diabetes treatment drug in Europe in 2000 and has continued to grow ever since. Last year, Takeda Pharmacies was reported to take 27 percent of its total revenue from the selling of Actos. The report states that the diabetes drug had reached $4.8 billion in sales up to March 31.  

Actos’ major competitor is Avandia, which is developed by GlaxoSmithKline. It has already been pulled in Europe following several cases which tied use to increased heart risks. Avandia also had an extensive list of restrictions which were placed on the drug in the United States.

Reference:

Hirschler, Ben. (July 21, 2011). “EU agency calls for new warnings on Takeda’s Actos.” Retrieved on July 25, 2011 from Reuters