Pradaxa is one of the newest blood thinners out there, and has become widely prescribed by physicians across the country. Unfortunately, a new body of research indicates that Pradaxa may be associated with serious adverse side effects, including:
Pradaxa is different than Warfarin and other anticoagulants because it doesn’t require medical monitoring blood tests. Unfortunately, failing to monitor the blood may have contributed to the high number of deaths associated with internal bleeding or hemorrhaging in Pradaxa patients. In addition, unlike older blood thinners, Pradaxa has no known antidote, which means that if you start to bleed out, there is no reversal agent readily available to stop the bleeding. Bleeding in Warfarin patients, on the other hand, can usually be treated with vitamin K.
In September 2011, officials in New Zealand launched a Pradaxa investigation following the reported deaths of as many as five elderly Pradaxa patients, caused by internal bleeding or hemorrhaging, and another thirty-six reports of patients suffering from serious Pradaxa bleeding side effects. According to claims made by family members, the chain of events which led to the patients’ deaths began when they switched from Warfarin to Pradaxa, and deadly infections set in after their conditions had significantly deteriorated. These reports from New Zealand followed a request by regulators in Japan for Boehringer Ingelheim to warn physicians about alleged Pradaxa side effects, including potentially deadly bleeding or hemorrhaging in some Pradaxa patients. Health officials sent a letter to the drug maker indicating that, between March 14 and August 11, 81 elderly Pradaxa patients suffered heavy bleeding or hemorrhaging, resulting in five fatalities.
In light of this potential Pradaxa side effect risk, the FDA has included a warning in the blood thinner’s medication guide indicating that Pradaxa can cause bleeding which can be serious, and may lead to death. In December 2011, the FDA issued a safety announcement indicating that the agency is evaluating post-marketing reports of serious bleeding events in patients taking the blood thinner Pradaxa. According to the FDA, bleeding that may lead to serious or even fatal side effects is a well-recognized complication of all anticoagulant therapies. But because of this life-threatening side effect risk, the Pradaxa drug label in particular contains a warning about significant and sometimes fatal bleeds. A new study published in the Archives of Internal Medicine also indicates that Pradaxa patients involved in the study had a 33% increased risk of heart attack or serious symptoms of heart disease, compared to patients taking Warfarin.
From the time when Pradaxa was approved, which was in October 2010, until August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed, and about 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies. If you or a loved one has suffered from a serious bleeding side effect, which you believe to be the result of Pradaxa use, contact an experienced Pradaxa attorney to discuss your options for legal recourse. You may be entitled to reimbursement for your injuries, the medical cost of treating your injuries, and the pain and suffering endured by you and your family, which you can collect by filing a Pradaxa lawsuit against drug maker Boehringer Ingelheim. Pursuing fair and timely compensation for your drug-related side effects can be a complicated process. With the aid of a qualified Pradaxa lawyer, you can concentrate on seeking proper medical care for your injuries, without having to devote time to filing an injury claim as well.