Intended Benefits of Xarelto. Johnson & Johnson (J&J) subsidiary Janssen Pharmaceuticals, along with Bayer Corporation, manufactures the anticoagulant, Xarelto. Xarelto (rivaroxaban) is part of a new generation of drugs that is touted as more convenient, offering freedom from mandatory blood level monitoring and stringent dietary restrictions.
However, with this convenience, patients have found there is a price to pay. That price is possible uncontrollable bleeding and other potentially life-threatening side effects.
The anticoagulant Xarelto is prescribed for up to six different medical conditions with the primary purpose to prevent excessive bleeding.
Xarelto’s blood-thinning properties are used to reduce the risk of stroke in patients with atrial fibrillation (irregular heartbeat). An irregular heartbeat can allow blood to be trapped in the upper chambers of the heart, which can cause blood clots to form. If a blood clot leaves the heart, it may travel to the brain and cause a stroke.
Xarelto is used to treat or reduce the reoccurrence of Deep Vein Thrombosis (DVT). DVT is a serious condition that occurs when a blood clot forms in a vein located deep inside the body. DVT occurs most commonly in people who are over 50 years of age. Certain conditions that change how blood moves through the veins can raise the risk of developing clots.
These include: having an injury that damages the veins; being overweight, which puts added pressure on veins in the legs and pelvis; having a family history of DVT; having a catheter placed in a vein; taking birth control pills or undergoing hormone therapy; heavy smoking; staying seated for a long time while in a car or on a plane. Deep vein blood clots typically form in the thigh or lower leg, but may also develop in other areas of the body.
Xarelto is also used to prevent Pulmonary Embolism (PE). Pulmonary embolism occurs when a blood clot gets wedged into an artery in the lungs. These blood clots most commonly come from the deep veins in the legs. PE can be life-threatening. Symptoms include unexplained shortness of breath, chest pain, or a cough that produces bloody sputum (phlegm).
Xarelto is also prescribed for the prevention of blood clots in patients following knee or hip replacement surgery. Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have been injured by defective drugs.
Serious Xarelto Side Effects
Unlike warfarin that has an available antidote, at this point, Xarelto has no known antidote or treatment to quickly restore clotting ability in the event of an internal bleeding episode, the need for emergency surgery, or a serious accident.
Reported side effects from individuals taking Xarelto include gastrointestinal bleeding. Symptoms of gastrointestinal (GI) bleeding are blood in stool or vomit that may look black or tar-like, reports the Mayo Clinic.
Another serious side effect is brain bleeding or hemorrhaging. A brain hemorrhage is a type of stroke. It is caused by an artery in the brain bursting and causing localized bleeding in the surrounding tissues. This bleeding kills brain cells. A brain hemorrhage is a life-threatening condition.
Symptoms include a sudden severe headache, seizures with no previous history of seizures, weakness in an arm or leg, nausea or vomiting, lethargy, changes in vision, tingling or numbness, difficulty in speaking or understanding speech, difficulty swallowing, loss of balance, and loss of consciousness, according to WebMD.
A study was conducted by Dr. John C Hwang and Dr. Judy H. Hun, because they became concerned of the potential danger appearing in reports to the FDA. The study involved the potential connection between Xarelto and strokes, clots, massive pulmonary embolisms, and uncontrollable hemorrhages in patients using the new generation blood thinner.
The doctors noted at least three patients had developed “spontaneous vitreous hemorrhage” also called eye bleeding. Their study also revealed that the potential for these adverse episodes seemed to be increased in patients who had switched to Xarelto from a more traditional anticoagulant.
Legal Issues Involving Xarelto
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. The blood thinner received a “black box” warning which is a distinction placed only on drugs that carry a significant risk of serious, life-threatening side effects.
Xarelto is in the same class of medications as Pradaxa. Pradaxa recently settled more than 4,000 individual cases against it for $650 million including more than 500 death claims.
After a decision in December 2014, multiple cases against Janssen Pharmaceuticals and Bayer AG have been consolidated in the Eastern District Court of Louisiana. This move affected about 21 current Xarelto cases.
There is a responsibility of drug manufacturers to sufficiently warn patients of potentially dangerous or life-threatening side effects that may occur as a result of taking their medication. It is alleged that Xarelto’s manufacturers neglected to properly inform medical professionals as well as the public of the potential risks they were taking by using this medication.