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The widely popular blood-thinner —generically known as rivaroxaban—is FDA-approved to reduce the risk of blood clots, deep vein thrombosis and pulmonary embolism in knee and hip replacement surgery patients and to reduce the risk of stroke and blood clots in patients with an abnormal heart rhythm, a condition known as non-valvular atrial fibrillation.
By decreasing the blood’s ability to clot, blood-thinners keep harmful clots from forming, helping to prevent heart attack, stroke, and blockages in the arteries and veins.
But uncontrolled bleeding has become a widespread problem, resulting in a litany of bleeding side effect lawsuits against the drug’s manufacturer, German pharmaceutical giant Bayer. Johnson & Johnson subsidiary Janssen Pharmaceuticals markets in the United States.
Hemorrhage—or uncontrolled bleeding—is listed as a common, and severe, side effect of . Symptoms of internal hemorrhage include coughing or vomiting blood, headache, red or black tarry stool, and spinal and epidural blood clots following a spinal tap or epidural.
While and its competitors Pradaxa (dabigatran) and Eliquis (apixaban) are touted as the new generation of blood thinners, lauded because there is no need for blood monitoring or dietary restrictions, they come with a frightening and potentially lethal risk: uncontrollable bleeding.
The lack of an antidote to stop a hemorrhage puts some patients at a high risk for bleeding out if they suffer an injury.
Additional bleeding side effects include bruising easily, particularly if taken with other medications including:
- St. John’s Wort
Patients taking Coumadin (warfarin)—an anticoagulant that had a corner on the market for some 60 years until the development of , Pradaxa, and Eliquis in the past decade—must regularly have their blood monitored and limit foods rich in vitamin K, particularly leafy, green vegetables like spinach, kale, cabbage, collard greens, and brussels sprouts. These vegetables could raise the risk of developing blood clots.
Fish, liver, grapefruit, cranberries, green tea, cranberry juice, and alcohol, can also reduce Coumadin’s effectiveness.
But there’s an antidote for Coumadin patients: Vitamin K, which helps the blood to clot.
There are more than 18,000 bleeding side effect lawsuits pending in federal and state courts, according to Reuters. A panel of federal judges in December 2014 created a multi-district litigation to more effectively manage the large number of cases.
The plaintiffs maintain that “was unreasonably dangerous and that J&J and Bayer, which jointly developed it, failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies,” according to Reuters.
Only two cases have gone to trial so far and the drugmaker prevailed in both, but lawyers representing the plaintiffs have vowed to “continue to press forward with the legal claims of the thousands of innocent victims of this drug.”
In 2014, Boehringer Ingelheim, which manufactures competitor Pradaxa, paid $650 million to settle claims of uncontrollable bleeding brought by thousands of patients.
If you or a loved one suffered an uncontrollable bleeding injury while taking , you may be entitled to compensation. Contact the experienced attorneys at McDonald Worley for a FREE case evaluation.