Pradaxa Patients Face Bleeding Risks Despite Antidote. The bleeding risk for people taking the blood-thinning drug Pradaxa is well documented, and the risk persists despite a recently developed bleeding antidote.
Many patients allege that the drug maker was reckless in introducing Pradaxa to the market with a bleeding reversal agent.
Pradaxa: First of the New Blood Thinners
For many years, warfarin was the only option for patients who needed an anticoagulant. But patients taking warfarin need regular blood monitoring to be sure they have the right amount of warfarin in their system. Too little, and the patient is at risk for a dangerous clots; too much leaves the patient at risk for uncontrollable bleeding.
Pradaxa (dabigatran) was approved by the U.S. Food and Drug Administration (FDA) in 2010, and has been widely prescribed to protect patients from the risk of blood clots and stroke. Pradaxa is taken to decrease the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (NVAF), a common heart rhythm abnormality. Dabigatran is also prescribed to treat and prevent deep vein thrombosis and pulmonary embolism from occurring again in patients who already have received other medicines and is taken to prevent deep vein thrombosis and pulmonary embolism after hip replacement surgery. Pradaxa works by preventing harmful clots from forming in the blood vessels.
Two other new anticoagulants quickly followed Pradaxa: Xarelto (rivaroxaban) in 2011 Eliquis (apixaban) in 2012. Pradaxa, Xarelto and Eliquis all came to market with the promise of greater ease and convenience than warfarin, the standard treatment for more than 60 years. Patients taking warfarin must have regular blood tests to monitor the level of the drug in their blood and adjust the dose if necessary. Warfarin users must also follow a careful diet to prevent interactions that would reduce warfarin’s effectiveness. The new medications were free of such restrictions, but patients soon began to report serious and troubling bleeding episodes.
The personal injury attorneys at Parker Waichman LLP are well informed about the risks associated with Pradaxa and other blood thinners and the firm offers free consultations to individuals with questions about filing a Pradaxa lawsuit.
Pradaxa Bleeding Risks
All anticoagulants-blood thinners-can pose a bleeding risk and doctors must monitor the patient to assure the safety and efficacy of blood thinners. The Mayo Clinic advises patients taking Pradaxa not to take other medicines-prescription or over-the-counter medicines and herbal or vitamin supplements-until they have discussed the medicine or supplement with a doctor.
Patients taking Pradaxa may bleed or bruise more easily while taking the drug and they should be careful to avoid situations where they could be cut, bruised or injured, including contact sports. A Pradaxa patient should contact the doctor right away if he or she has unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, unusual nosebleeds. Women should contact a doctor if they experience unusual vaginal bleeding or menstrual bleeding that is heavier than normal.
Pradaxa and other anticoagulants work by inhibiting the body’s clotting mechanism, which improves blood circulation. But when an individual taking an anticoagulant experiences internal bleeding or bleeding from a wound, restoring clotting ability can be critical to preventing serious or even fatal bleeding. An injury can become life threatening if bleeding cannot be controlled. And it can sometimes be necessary to quickly reverse anticoagulation if a patient taking an anticoagulant needs emergency surgery. Warfarin has a readily available antidote to restore clotting ability.
A Pradaxa bleeding antidote, Praxbind, was approved in 2015, but patients can only receive the antidote from a hospital.
By 2011, the FDA had received 817 reports of Pradaxa bleeding complications with thousands more submitted in other databases. In total, there were 3,781 Pradaxa bleeding injuries with more than 500 of them being fatal.
A recent study by the University of Pittsburgh reports that approximately nine percent of Pradaxa patients had experienced major internal bleeding complications compared to six percent of warfarin patients. Plaintiffs in Pradaxa lawsuits, allege that Boehringer Ingelheim allegedly failed to warn patients of the bleeding risks.
In addition, in reports to the FDA and in legal documents, patients taking Pradaxa, Eliquis, and Xarelto dispute the uniform dosing and lack of blood monitoring. Some patients say that because of differences in size, weight, and metabolism, some patients may not be getting an adequate dose. Patients say there should be monitored to determine if they are receiving the proper dose.