Pradaxa Linked to Gastrointestinal Bleeding, Death
Nearly 700,000 strokes occur in the United States every year. Accounting for nearly 15% of these attacks is a disease affecting over two million Americans, known as atrial fibrillation (Afib). While aspirin type medicines are helpful in combating the risk of a stroke occurring, patients suffering from Afib have recently begun turning to a drug commonly known as Pradaxa to help prevent the onset of strokes. Pradaxa is marketed as a safer and more effective alternative to aspirin type medications, however, this drug has recently begun to show its true colors as a disturbingly more dangerous, and less effective product than advertised.
One aspirin type product in particular, Coumadin, has been the poster-drug for stroke prevention. Despite this drugs effectiveness, it is ultimately highly underutilized by persons suffering from Afib. Due to the necessity for regular blood tests, and restricted food and drug interaction, less than half of persons at risk for strokes choose to use Coumadin. Enter Pradaxa: offered as a product not requiring regular blood tests or food and drug restrictions.
Behind a massive promotional campaign, and extensive marketing, Pradaxa was prescribed over 250,000 times in the first six months of its introduction on October of 2010. By June of 2012, over 3.2 million prescriptions had been written for Pradaxa.
Unfortunately, the skyrocketing sale of this product carried with it potentially grim consequences for those using Pradaxa. Within six months of sales, over 900 reports of adverse side affects from Pradaxa were made. Shockingly, over 100 deaths were reported in users of Pradaxa over the same time period. By December of 2011, the number of deaths associated with Pradaxa had ballooned to over 500.
The adverse affects associated with Pradaxa are commonly internal bleeding and hemorrhaging. Given the fact that many cases are often under represented, the instances of adverse affects and death associated with Pradaxa are likely much higher than reported. Surprisingly, the risk associated with this product became apparent in early clinical trials. Patients using Pradaxa were found to be 50% more likely to suffer gastrointestinal bleeding, and persons over the age of 75 were found to be placed at a higher risk of all bleeds. The cause of these adverse affects is essentially unknown. Hypotheses exist that the acid in Pradaxa capsules is to blame for this gastrointestinal bleeding. A second hypothesis for the alarming number of adverse affects associated with Pradaxa is that there exists no antidote to reverse the harms Pradaxa creates. Conversely, health care providers have numerous means to combat the adverse affects of Coumadin, thus the ability to counteract any internal bleeding that could be fatal. Unfortunately, the same process cannot be done due to reverse the harms of Pradaxa due to the drugs design; nor can the blood thinning effects of Pradaxa be effectively monitored.
Combined, the inability to reverse the effects of this drug, and the lack of a method to monitor the blood thinning occurring from Pradaxa creates an extremely dangerous and life-threatening product. Despite showing these warning signs early in clinical trials, Pradaxa passed under the FDA=s radar namely because of its claim to be more effective than Coumadin: thereby making the risks associated with Pradaxa appear secondary to the benefits. However, studies have recently begun to show that Pradaxa is only marginally more effective than its competitor, Coumadin, at reducing the risk of strokes. Patients using Pradaxa have a stroke rate of 1.11% while patients using Coumadin have a stroke rate of 1.69%, an absolute difference of merely 0.58%. While the results of this study are in dispute, due to late changes and delays in finalizing these findings, health care professionals have come to express serious concerns about whether the harms caused by Pradaxa are outweighed by the at best, slight, benefits.
As of June of 2012, 20 cases have been filed in 9 federal courts against the manufacturers Pradaxa. If you or a loved one has been harmed by the use of Pradaxa, the Clark Law Firm, PC is here to help. We do not stand for companies introducing harmful products into the marketplace, and neither should you. A drug with suspect test results, no available antidote, and no way to monitor its harms until it=s too late is a blatant threat to our community and an unjustifiable risk to patient=s health and well being. Act now if you or a loved one believes there may have been an injury from Pradaxa, or lost a loved one to this product. The experienced personal injury attorneys at the Clark Law Firm, PC are willing to fight to protect your interests. Contact our New Jersey trial attorneys today and speak up against Pradaxa.