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Actos Sales Suspended in Germany, France over Bladder Cancer Fears | cialis online

Actos Sales Suspended in Germany, France over Bladder Cancer Fears

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German and French drug regulators suspended the sale of Type-2 diabetes drug Actos citing study results linking the drug to an increased risk of bladder cancer. On Thursday, the French Health Products Safety Agency (AFSSAPS) announced the suspension of pioglitazone-containing drugs and on Friday Germany did the same. Actos, known generically as pioglitazone, was approved in 1999 to lower glycemic levels in adults with Type-2 diabetes, which is caused when the body no longer responds to insulin resulting in overeating and lack of exercise.

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In 2008, Actos was the 10th-best selling drug in the U.S. with sales exceeding $2.4 billion, reported the Wall Street Journal. The French study, conducted by the nation’s insurance company, compared 155,000 patients in France taking pioglitazone from 2006 to 2009 to 1.3 million diabetics not using the drug. Researchers found an “adjusted hazard ratio of 1.22 (95 percent CI 1.05 to 1.43) for bladder cancer” among

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those taking the drug, says MedPage Today. The study also revealed a dose effect among those receiving a cumulative dosage of 28,000 mg or more resulting in an increased risk of bladder cancer. Despite the study results, the European Medicines Agency (EMA) released a statement saying it will not pull the drug. The agency’s Committee for Medicinal Products for Human Use is reviewing clinical and non-clinical data from pharmacoepidemiological studies and post-marketing reports to determine the benefits and risks of pioglitazone-containing drugs, says MedPage Today. The EMA committee will meet later this month to discuss the reviewed data. This news could devastate the future of drug manufacturer, Takeda Pharmaceutical Co. The Japanese company is cooperating with AFSSAPS and emphasized the French agency’s decision was based on a small increased risk of bladder cancer found in a French study, says the Financial Times. Takeda is confident in the benefits of pioglitazone and will release study results in 2015 on any possible concerns about the drug. In 2010, the U.S. Food and Drug Administration (FDA) issued a safety announcement on Actos after review of an on-going, ten-year epidemiological study suggested an increased risk of bladder cancer. Based on the results, the agency determined further analysis of the issue is necessary. The study included data from the Kaiser Permanente health plan and examined roughly 30,000 patients using pioglitazone and 160,000 other diabetics, reported MedPage Today. Researchers found no increased risk of bladder cancer; however, an increased risk was observed among those taking Actos for at least two years and in patients exposed to the highest cumulative dose of the drug, reported the FDA. Another pioglitazone-containing drug called Compectact was included in the suspension. The AFSSAPS suspension will go into effect next month so patients using Actos or Compectact can switch to other medications. Approximately 230,000 people in France are currently using one of the drugs, reported the Wall Street Journal.

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