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Xarelto May Cause Wound Complications After SurgeryJan. 26, 2015
W&L today announced it has expanded the scope of cases being accepted on behalf of patients injured by the anticoagulant drug Xarelto. This includes cases of individuals who took the medication and suffered wound-site complications following a total hip or knee arthroplasty.
The drug has been approved by the FDA for thromboprophylaxis after either procedure. Taking the medicine after such surgery is indicated to prevent the complications of deep-vein thrombosis (DVT) and pulmonary embolism (PE).
However, it appears that prophylactic doses of Xarelto —those given in order to help prevent DVT or PE after total hip or total knee arthroplasty can produce disturbingly high wound complication rates.
Previously, doctors typically prescribed prophylactic doses of low-molecular-weight heparin, a different type of anticoagulant or aspirin, and simple mechanical means such as compression stockings and DVT compression pumps. Many orthopedists still use these tried and true safer methods of DVT prevention instead of Xarelto.
The wound complications attributed to prophylactic doses of Xarelto after total hip or total knee arthroscopy include infection, abnormal drainage, alarming levels of oozing, hematoma, poor range of motion and unrelenting pain.
Xarelto Users May Need Reoperation
Patients experiencing any of these Xarelto wound complications could need to undergo reoperation.
A 2011 study by a group of orthopedic surgeons in the U.K., published in the Journal of Bone & Joint Surgery, looked at more than 1,000 total hip and total knee arthroplasty patients and found that of the 31 requiring reoperation, 22 had been given prophylactic doses of Xarelto.
Of those who instead were given prophylactic doses of a low-molecular-weight heparin after arthroplasty, only nine needed to return to the operating theater. Notably, this higher rate of reoperation in the Xarelto-treated patients is statistically significant.
In the Nov. 13, 2008 edition of the New England Journal of Medicine, an orthopedic surgeon who was a member of a steering committee for a rivaroxaban trial wrote that he would not recommend Xarelto for his patients.
He explained that the prevalence of fatal pulmonary embolism after total knee arthroplasty is a mere 0.1 percent overall, while the risk of bleeding consequences accompanying use of anticoagulants is a far greater 3.0 percent.
In other words, the risk of harm from Xarelto could significantly outweigh the risk of a pulmonary embolism.
Other Xarelto Dangers
Xarelto is a specific type of Factor Xa inhibitor anticoagulant that has been on the market since the U.S. Food and Drug Administration approved it in 2011.
The pharmaceutical company Bayer created the medication, and licenses the right to manufacture and market it to the Johnson and Johnson affiliate Janssen.
Beside arthroplasty patients, Xarelto is prescribed to atrial fibrillation patients to help prevent strokes and other l events that might result from blood clots.
Unfortunately, Xarelto can at the same time produce a risk of serious internal bleeding, including hemorrhagic stroke, brain hemorrhage and gastrointestinal bleeding, according to various studies.
In 2014, the U.S. Food and Drug Administration approved additional language for Xarelto’s package labeling to warn about some but not all of the risks of bleeding events. The Xarelto label warnings now make reference to discourage use of the drug in some kidney patients, pregnant women, nursing mothers and patients with prosthetic heart valves. However, it does not warn patients about the wound infection risk nor does it adequately warn patients about the lack of an antidote in the event of a hemorrhage.
If you or a member of your family, after taking Xarelto, suffers any of the complications described above, do not hesitate to contact W&L. The fact is you may need a legal remedy to help you pay the costs of medical care to correct the harm done by Xarelto, as well as to help you recover for pain and suffering.