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Investigation: Pradaxa most complained about U.S. drug; blamed for deaths, life-threatening injuriesCLEVELAND - A Five On Your Side Investigation found Pradaxa, a popular blood thinner,  is the most complained about drug in the United States.Our research found more complaints were filed with the FDA about Pradaxa than any other prescription drug in both 2011 and 2012.Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries, according to Tom Moore, the senior scientist for drug safety and policy at the Institute for Safe Medication Practices. The ISMP is a non-profit organization that monitors FDA reports.The drug is used to treat atrial fibrillation, a heart condition that significantly increases the risk of stroke."We've found that this drug had a potential benefit in preventing stroke, but it also had extremely high risk of bleeding as do some other anti-coagulants,” said Moore.Court Order Reveals Hidden DocumentsEarlier this month, as the result of an Illinois court order, documents were released that revealed the drug’s manufacturer, Boehringer Ingelheim, performed a study that showed a small minority of patients could have a higher bleeding risk.The documents also show the German based company knew regular blood tests could help manage the bleeding risk.However, in an internal e-mail obtained by 5 On Your Side Investigators, a supervisor expressed concern requiring monitoring could hu...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs