The blood-thinning drug Pradaxa (dabigatran) has been linked to a number of serious complications, including an increased risk of serious and in some cases, fatal, bleeding events. Boehringer Ingelheim, the company that manufactures Pradaxa, acknowledged in November 2011 that the drug was responsible for approximatley 260 deaths worldwide. A new report issued by the Food and Drug Administration (FDA) last week suggests that additional patient deaths may be attributed to Pradaxa in the U.S.
The Institute for Safe Medication Practices released a new QuarterWatch report on April 5th. QuarterWatch tracks adverse event reports submitted to the FDA for each quarter of the year. The April 5th issue included data for the second quarter of 2011, which ran from the beginning of April through the end of June. According to the report, Pradaxa was associated with 856 reports of serious, disabling or fatal injury in the second quarter of 2011, including 117 patient deaths and 511 cases of bleeding events. The majority of Pradaxa bleeding events reported involved patients who were over the age of 80.
The QuarterWatch report reinforces other research studies which have linked Pradaxa to an increased risk of serious or fatal bleeding events, particularly in older patients. Last month, a group of Utah researchers published a case study which indicated that older patients who use Pradaxa may be at risk for a fatal bleeding event after an elderly man died due to a severe cerebral hemorrhage triggered by a minor fall. Additional studies have suggested that the drug may be dangerous for patients who are suffering from moderate to severe kidney failure or those who are undergoing ablation therapy to treat atrial fibrillation (AF). Ablation therapy involves electrical stimulation of the heart.
Pradaxa was first approved by the FDA in 2010 to treat patients suffering from AF. Atrial fibrillation is a heart rhythm condition that can cause blood clots to form in the lungs, potentially leading to pulmonary embolism, heart attack or stroke. Boehringer has claimed that Pradaxa may be effective in preventing as many as 5,000 strokes per year in patients diagnosed with AF. The drug has been widely touted as a safer alternative to another anticoagulant medication known as warfarin, which has also been linked to serious bleeding events and requires patients to undergo stringent monitoring in order to reduce the risk of complications.
Boehringer is facing a handful of wrongful death lawsuits in the U.S. filed on behalf of patients who claim Pradaxa caused the untimely death of their loved one. The plaintiffs allege that the company was aware of the potential risks but failed to adequately warn consumers of the dangers. The FDA says it will continue to investigate the safety of Pradaxa but as of yet, no plans have been announced to recall the drug from the market. Patients who believe they were injured after using Pradaxa are encouraged to seek the aid of an experienced Pradaxa attorney to determine whether they may be entitled to compensation for their medical bills, lost wages and pain and suffering.