For years, the Food and Drug Administration has been comparing Medicare patients who have been using Pradaxa and Coumadin or Wafarin as it is often called in terms of their risk factors. Basically, many of the risks that those taking either drug includes bleeding in the gastrointestinal (GI) tract, myocardial infarction (MI), stroke, bleeding in the brain and even death. The seriousness of the side effects being studied is rare, but they are such that the consequences have been paramount for those taking the drugs.
Effects of Pradaxa
In one study, over 134,000 Medicare patients who were at least 65 years old and using both products showed that there were significant differences between both. Those who used Pradaxa were shown to have lower cases of brain bleeding, clot-related strokes, and dying prematurely as compared with Coumadin. However, the risk of MI was determined to be similar for both drugs.
In making a direct comparison, Pradaxa did have an increase of bleeding in the GI as compared to Coumadin which has certainly garnered the interest of the scientific community because such bleeding may be difficult to detect or discern from other conditions. The studies have also shown that the risks to those who take Pradaxa actually increase with age, although both drugs do have their own case of side effects. In fact, new users of Pradaxa have shown fewer cases of GI bleeding or internal hemorrhages based in part upon their younger age. Those who are entering their 60s seem to do better than those who are in there 70s or 80s.
What has also been found is that such cases of bleeding are less prevalent amount Pradaxa users as opposed to Coumadin if they had just started taking the drug and were in their mid-60s. The FDA is committed to further studies and investigations to track the location and differences in any bleeding or abnormality. In this manner, further differences between the drugs will be understood.
What Does Pradaxa Treat?
Currently, Pradaxa actually reduces the risk of systemic embolism and stroke in non-valve atrial fibrillation cases, pulmonary embolism as well as treatment of deep-vein thrombosis. The ability of Pradaxa to reduce this risk is has led to its further use for patients who are also taking a parenteral anticoagulant for the past five to ten days. This is to reduce the reoccurrences of PE and DVT.
Treatment with Coumadin
Coumadin is used to treat pulmonary embolism, thrombosis and thromboembolic complications due to atrial fibrillation. In addition, this treatment is also used for cardiac valve replacement to help reduce the risk of premature death from occurring.
It is clear that both drugs have benefits and side effects that will need to be carefully monitored. The differences between them are relatively small and will depend in large part on the age, health and wellbeing of the patient. While studies will continue with both drugs for the foreseeable future, any differences between them are really based more on the condition of the patient and the particular issues that they may be facing in the near future.