Pradaxa is one of the new class of blood-thinning medications intended to reduce the risk of stroke and systemic embolism in patients with irregular heartbeats. Produced by German pharmaceutical company Boehringer Ingelheim, Pradaxa entered the market in October 2010, designed to replace the well-studied and widely used warfarin (sold as Coumadin, Jantoven, or Marfarin).
While clinical results conducted by Pradaxa’s manufacturer looked promising, the results of those same clinical trials have been called into question by information that Boehringer Ingelheim did not reveal at the time that Pradaxa was brought onto the market. In addition, Pradaxa has caused several serious and deadly complications since its introduction in numbers that significantly exceed it clinical trial data.
With a recent multimillion dollar settlement stemming from the drug’s dangerous side effects, more people are asking “What is Pradaxa?” and “Is it safe?”
Pradaxa is the brand name for dabigatran etexilate. It is a new prescription blood thinning medication used to prevent stroke and blood clots in patients with non-valvular atrial fibrillation, the most common type of abnormal heart rhythm. The anticoagulant capsules work by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting.
Pradaxa is manufactured by German-based Boehringer Ingelheim and marketed as an alternative to Coumadin (warfarin), a widely used anticoagulant. It is the first oral anticoagulant approved by the FDA in more than 50 years. Since its October 2010 FDA approval, acceptance and use of Pradaxa spread quickly. From October 2010 through August 2011 about 1.1 million prescriptions were dispensed in the U.S. and about 371,000 patients received the prescriptions from U.S. outpatient retail pharmacies.
Comparing Pradaxa to Coumadin
Studies show Pradaxa is associated with fewer drug and food interactions than Coumadin, and unlike Coumadin, routine blood level monitoring of patients taking Pradaxa is not required, so there is a convenience factor. But also unlike Coumadin, which first became FDA approved in the 1950s, knowledge of Pradaxa is limited.
When comparing Pradaxa to Coumadin in a large clinical trial involving 18,113 patients, the study showed those taking Pradaxa had fewer strokes than those using Coumadin. Hemorrhaging occurred at similar rates with both Pradaxa and Coumadin.
A big difference between the two drugs is that there is currently no antidote or way of reversing Pradaxa in cases of dangerous bleeding. If such bleeding occurs in patients taking Coumadin, Vitamin K can be administered.
Reports of Serious Bleeding in Patients Taking Pradaxa
In just over a year after approving Pradaxa, the FDA issued a safety announcement about reports of serious bleeding events in patients taking the drug. In the announcement, the FDA stated that serious and even fatal bleeding can occur when taking any anticoagulant therapy, but the FDA is working closely with the manufacturer of Pradaxa to evaluate post-market reports of bleeding.
Pradaxa’s Purported Benefits Outweighed by Risks
Pradaxa (dabigatran etexilate mesylate) was marketed as an improvement over similar time-tested drugs as it supposedly required less medical monitoring. In addition, Pradaxa only has two different dosages, which was supposed to make it easier for doctors to ensure patients were getting adequate and appropriate amounts. Even better news for atrial fibrillation patients – Pradaxa required fewer dietary restrictions and had fewer adverse interactions with other medications.
However, since its introduction to the market, Pradaxa has been linked to hundreds of deaths across the globe. In just the United States in 2011, Pradaxa was linked to over 500 deaths. Pradaxa also led reports of complications for all anticoagulants, causing over 3700 reported incidents. This is more than three times the number reported for similar medications, such as warfarin.
Contact Raizner Slania Today for Your Pradaxa Claim
If you or a loved one experience excessive bleeding or other side effects of Pradaxa, consult with your physician right away. If an emergency exists, such as excessive bleeding, get help immediately. The law firm of Raizner Slania continues to investigate claims of deaths and serious injuries in patients taking Pradaxa (Dabigatran).