On the heels of the first Pradaxa lawsuits alleging bleeding injuries having been filed last month, two new scientific reports continue to raise questions about the safety of Pradaxa (Dabigatran).
The first report, put out by the Institute for Safe Medication Practices, notes that both of the major blood clotting inhibition medications, warfarin and Pradaxa, remain among the most dangerous outpatient treatments currently practiced in the United States, accounting for up to one-third of all emergency hospitalizations for drug side effects among the elderly. Moreover, and of particular concern, the ISMP report also says that Pradaxa was a suspected drug in over 800 cases of serious or fatal injuries recorded in the second quarter of 2011, including over 100 reported patient deaths potentially tied to Pradaxa.
The report singled out hemorrhages after accidents like falling and hemorrhagic strokes among elderly patients. These numbers unfortunately further confirm fears of patient advocates medical researchers that Pradaxa may be more likely to cause bleeding injuries than previously suspected, an outcome that may be tied to the lack of any available reversal agent for the medication.
A second report, a meta-analysis of studies published in the Annals of Internal Medicine, didwit did find that the injury rates attributed to warfarin might be lower than believed by the FDA when it approved Pradaxa. The study thus raises further questions about whether patients and physicians are fully informed about the true risks and benefits of Pradaxa. In the end, it may be that Pradaxa is no more effective in preventing ischemic strokes yet has higher rates of serious or fatal bleeding, including gastrointestinal and intracranial bleeding.
Given the severity of the problem, and the frequency with which we see blood thinning medication overdoses, our pharmaceutical product liability and medication error attorneys will continue to monitor the latest research on Pradaxa.
The studies are available here: