Pradaxa (dabigatran etexilate mesylate) is a blood-thinning medication (anticoagulant) manufactured by Boehringer Ingelheim. This medication is prescribed to reduce stroke risk and blood clots in patients with atrial fibrillation that is not caused by heart valve problems. Atrial fibrillation is a rapid and irregular heart condition which results in poor blood flow throughout the patient’s body. This medical condition is typically controlled and treated with blood-thinning medications such as Pradaxa.

 Pradaxa has been on the U.S. market since it was approved for sale by the Food and Drug Administration (FDA) in October 2010. The drug is widely used for treatment of atrial fibrillation in the U.S. The FDA reports that from October 2010 through August 2011, approximately 1.1 million prescriptions of Pradaxa were distributed. Furthermore, during the same time period, approximately 371,000 patients obtained prescriptions for this drug from U.S. pharmacies.

 On December 7, 2011, the U.S. Food and Drug Administration (FDA) issued a drug safety communication indicating a safety review would be undertaken by the agency to assess post-market reports linking serious bleeding events with the use of Pradaxa. In January 2012, Boehringer Ingelheim modified the Prescribing Information for Pradaxa to include a warning on the increased risk of bleeding which may result from taking the drug. The warning includes an extremely concerning statement indicating that “Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.”

Several studies have raised concerns regarding the increased risk of serious bleeding resulting from the use of dabigatran drugs such as Pradaxa. The Institute of Safe Medication Practices (ISMP), a nonprofit organization that analyzes the U.S. Federal Drug Administration’s (FDA) adverse drug event reports, found that “within 12 weeks of initial marketing approval in October 2010, dabigatran (Pradaxa) was the suspect drug in 307 serious adverse events…” Furthermore, within the first few months of 2011, “more than 500 reports of fatal, disabling and other severe hemorrhages” were filed with the FDA’s adverse drug event reporting system.

Peer-reviewed journal articles have also cited evidence of an increased risk of developing acute coronary syndrome or other serious heart conditions as a result of taking Pradaxa. A 2012 study published by the Archives of Internal Medicine found that “Dabigatran is associated with an increased risk of myocardial infarction (MI) or acute coronary syndrome (ACS) in a broad spectrum of patients…” Furthermore, researchers at the Cleveland Clinic recently found that patients taking Pradaxa have a “33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin.”