Jansen Pharmaceuticals’ new anticoagulant drug Xarelto (rivaroxaban) has recently been linked to blood clots, internal bleeding, and other serious side effects. While Xarelto has been shown to require less intensive monitoring than its major competitor warfarin, reports have shown that it may result in severe blood clots and internal bleeding events that could be extremely difficult to treat. Signs and symptoms of Xarelto-induced internal bleeding may include blood in the urine or stools, vomiting blood, and any unusual bleeding.
Free Xarelto Lawsuit Evaluation: If you or a loved one has been diagnosed with internal bleeding after being treated with Xarelto, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Xarelto and we can help.
What is Xarelto?
Manufactured and marketed by Jansen Pharmaceuticals, Xarelto is an anticoagulant blood thinner designed to prevent the formation of blood clots. Xarelto was approved by the U.S. Food & Drug Administration (FDA) in July 2011 for the prevention of a type of blood clot known as deep vein thrombosis (DVT), a condition that commonly occurs after certain types of surgeries. The drug is also commonly prescribed to reduce the risk of stroke in patients with a certain type of heart rhythm disorder. Xarelto belongs to a class of drugs known as factor Xa inhibitors, which includes the much-troubled Pradaxa (generic: dabigatran).
Xarelto & Internal Bleeding
Unfortunately, Xarelto has been linked to an increased risk for internal bleeding events. Signs and symptoms of Xarelto-induced internal bleeding may vary, depending on the location of the bleeding, and what body functions are affected. Symptoms of internal bleeding may include:
- unusual bleeding
- discolored urine (blood in the urine)
- red or black-colored stool
- coughing up blood
- vomiting blood that looks like coffee grounds
- frequent nose bleed or gum bleeding
- weakness and swelling in the extremities
According to a new study conducted by researchers in Australia, Xarelto presents less of a risk of bleeding in the brain than Coumadin (warfarin) when given to patients with atrial fibrillation, but like Pradaxa, Xarelto may cause more serious bleeding events that could be difficult to treat. The FDA has announced that it is currently in the process of evaluating bleeding events in patients being treated with Xarelto to determine whether the risks outweigh the benefits of the drug.
Xarelto Blood Clots
Although excessive bleeding events are the most commonly reported serious side effect associated with Xarelto, there has been increasing concern about the development of blood clots in patients who are administered Xarelto as a prophylaxis. These patients tended to be a younger group [median age 66] who took Xarelto after hip or knee replacement surgery. According to a report issued by the Institute for Safe Medication Practices (ISMP), of the 356 adverse events reported in the first quarter of 2012, at least 158 cases of blood clots or thromboembolic events were reported to the FDA.
Signs and symptoms of a Xarelto blood clot may include:
- exhaustion or unexplained fatigue
- redness, inflammation or varicose veins
- shortness of breath
- chest pain or pain with deep breathing
- fever or sweats
- dizziness or fainting
- increased heart rate
- unexplained cough
- asymptomatic (no symptoms)
- bloody mucus with worsening cough
Xarelto Side Effects
In addition to having the potential to cause blood clots and serious internal bleeding events, Xarelto has also been associated with a number of less severe side effects such as:
- severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
- bloody or black, tarry stools
- coughing up blood
- dark urine
- sore throat
- pain or new drainage at wound sites
- pink or red urine
- red, swollen, blistered, or peeling skin
- stiff, sore, hot, or painful joint
- symptoms of anemia (e.g., unusual paleness, severe or persistent headache, shortness of breath, fast heartbeat, chest pain, unusual tiredness or weakness)
- symptoms of bleeding in the brain (e.g., sudden, severe headache; one-sided weakness; vision problems; slurred speech; confusion)
- symptoms of low blood pressure (e.g., fainting, light-headedness, severe or persistent dizziness)
- unexplained swelling
- unusual or prolonged bruising or bleeding
- vomit that looks like coffee grounds
- yellowing of the skin or eyes (jaundice)
Xarelto & Pregnancy
The FDA currently classifies Xarelto in Pregnancy Category C, which means that it is not known whether the drug will cause harm to an unborn baby. However, Xarelto has the potential to cause bleeding complications during childbirth. If you are currently taking Xarelto, consult your doctor immediately if you become pregnant. Additionally, it is not known whether Xarelto has the ability to pass into breast milk, or if it could cause harm to a nursing baby. The FDA has advised women who are breastfeeding not to initiate treatment with Xarelto.
Do You Have a Xarelto Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xarelto lawsuits. We are handling individual litigation nationwide and currently accepting new internal bleeding cases in all 50 states.
Free Xarelto Lawsuit Evaluation: If you or a loved one has suffered from an internal bleeding event after being treated with Xarelto, you should contact our law firm immediately. You may be entitled to compensation by filing a Xarelto internal bleeding suit and we can help.