Recent medical research indicates that Coumadin and its generic version, warfarin, are highly effective in preventing strokes. Pradaxa, a newer anticoagulant is attempting to gain market share from the much less expensive alternative. Pradaxa, was introduced by Boehringer Ingelheim as a superior alternative to Coumadin/warfarin.
According to a study published in the Archives of Internal Medicine, researchers found that stroke rates very low among warfarin users, and the numbers seem to be improving over time. Warfarin is highly effective in stroke prevention among patients who have nonvalvular atrial fibrillation, which is the same group of people that Pradaxa has been approved to treat.
According to the editorial, the results indicate that warfarin is likely to continue to be the go-to anticoagulant for some time.
Pradaxa (dabigatran) was introduced in October 2010, and Pradaxa has become very widely used because of aggressive marketing by the drug maker, Boehringer Ingelheim.
Recently there is a cause for alarm about the risk of internal bleeding from Pradaxa side effects, which have caused hundreds of reports of death and catastrophic hemorrhages.
Pradaxa was the first approved anticoagulant from in a new class of anticoagulants, known as “direct thrombin inhibitors”, which inhibit the enzyme in the blood that causes blood to clot.
These medications are promoted as superior alternatives to Coumadin/warfarin because they require less monitoring. Users of warfarin who suffer internal bleeding can be treated with Vitamin K injections, and fresh frozen plasma infusions to counteract the blood thinning effects. Pradaxa and the other newer blood thinners in the same class do not have an antidote.
The only viable treatment for Pradaxa bleeding side effect is dialysis, which is complicated and has its own side effects and risk profile.
Emergency room physicians and other medical experts have raised alarm about their inability to treat hemorrhages or other bleeding events that do occur.
In this study, researchers looked at patients being treated with warfarin and found that the annual rate of incidence for stroke or systemic embolism was only 1.66% for patients given warfarin.
They found that major bleeding events occurred in 1.4 to 3.4% of patients per year. Researchers indicate those numbers have been declining over the years, showing that the use of warfarin has been increasing in effectiveness.
This support for use of the older and cheaper Coumadin, combined with increasing concerns about the safety of Pradaxa, may cause doctors to back off of use of the heavily promoted newer anticoagulant.
Many injured patients are now filing lawsuits over Pradaxa, alleging that Boehringer Ingelheim provides inadequate warnings about the risk of internal bleeding and lack of a reversal agent.
According to a report released by the Institute for Safe Medication Practices, there are substantially more adverse event reports being submitted to the FDA involving Pradaxa bleeding events than with Coumadin/warfarin. During the first quarter of 2011, at least 505 instances of hemorrhages with Pradaxa were reported, compared with 176 cases reported involving warfarin/Coumadin, which was second on the list.
In December 2011, the FDA announced that it was reviewing post-marketing reports of Pradaxa bleeding problems to determine if there was anything abnormal about the side effects of the medications and whether the newer anticoagulant may pose an unreasonable risk for certain consumers.
In March 2012, Canadian health officials announced that new label warnings wold be added to Pradaxa, indicating that individuals with kidney problems may be at an increased risk of bleeding from Pradaxa. Doctors were cautioned to have patients’ renal function assessed before starting Pradaxa and to routinely assess any changes in kidney function while the medication is used, especially among elderly users.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.
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