FDA’s Pradaxa Study Criticized

The Food and Drug Administration recently released a report that showed that the bleeding risks of Pradaxa are comparable to the risks associated with a competing, older drug, known as warfarin. Many patients are skeptical of this report, as the Food and Drug Administration relied on data and insurance claims to come to this conclusion and the methodology used to come to this conclusion has been criticized.

Pradaxa was marketed by drug maker Boehringer Ingelheim as a superior blood thinning medication in comparison to warfarin, an older medication that requires more complicated maintenance of diet and blood levels by patients, when it was first approved for the market in 2010. However, unlike warfarin, there is no antidote to bleeding that can occur in patients who are taking the medication.

Patients suffer uncontrolled bleeding

With any blood thinning medication, there is a degree of risk that patients will suffer internal or otherwise problematic bleeding because the medication stops clots from forming as they usually might. The Food and Drug Administration announced in 2011 that it was investigating an increase in adverse event reports that had been issued in relation to the medication, but concluded that the rates of bleeding for Pradaxa and warfarin are ultimately comparable.

The Pradaxa warning label acknowledges that the medication puts patients at an increased risk of dangerous bleeds and other episodes. However, it doesn’t mention the fact that there is no antidote to this bleeding, and that there is this antidote for warfarin, the alternative to the medication. This omission could lead many patients to believe that there is no significant risk that Pradaxa presents over warfarin.

Researchers have noted that there is no evidence that bleeding risks related to Pradaxa are more significant than the risks related to warfarin, but some agencies and patients claim that the risk of bleeding is not the issue–it is the fact that the bleeds are difficult to control, and therefore could do more significant damage.

Injured plaintiffs seek compensation

Patients who have been injured by Pradaxa bleeding or complications sometimes seek the assistance of a Pradaxa lawyer in order to file suit against drug maker Boehringer Ingelheim. These plaintiffs are hoping for compensation for their injuries, and a number of Pradaxa lawsuits are currently taking place in courts throughout the country.