Xarelto is an anticoagulant medication used to treat blood clots that can lead to serious – even fatal – health complications, such as stroke or heart attack. Xarelto is used to prevent blood clots in a variety of circumstances and is prescribed to patients with a history of deep vein thrombosis or pulmonary embolism, as well as rapid heartbeat unrelated to valve problems, atrial fibrillation, or following knee or hip replacement surgery. The drug is manufactured by Bayer HealthCare and is marketed in the United States by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

Anticoagulants are one of the most popular medications on the market today, generating sales of more than a billion annually. Xarelto became the most common anticoagulant prescribed since within three years of its FDA approval in mid-2011.

What Made Xarelto So Popular?

Xarelto works by decreasing the production of thrombin, the chemical that causes fibers to form into blood clots. It was originally thought to be a better option than other anticoagulants for a few reasons.

Unlike other anticoagulants, Xarelto uses a standard dose for all patients within a specific profile. With other anticoagulants, constant monitoring of dosage is required, as are medical tests to ensure there are no changes needed in dosage. Patients must also make dietary changes when taking those medications, something that is not required for users of Xarelto.

Without ongoing medical testing, users are not required to schedule frequent checkups. They take their oral dose of Xarelto and enjoy relatively few changes as a result of their medical circumstances. Unfortunately, this reduced medical attention might add to the risk patients experience when using Xarelto. Problems can begin suddenly and without warning, and without ongoing attention from a doctor, damage can be done before a patient realizes there is a problem.

Xarelto Side Effects

Xarelto has been shown to trigger a variety of side effects ranging from mild to fatal. Some of the reported side effects include:

• Nausea and vomiting
• Dizziness
• Headache
• Low blood pressure
• Muscle pain
• Swelling and edema
• Unusual bleeding from the eyes, nose, gastrointestinal system, rectum, urinary tract or genitals
• Unexplained bruising

One of the main concerns associated with Xarelto is the medication’s ability to trigger internal bleeding in any part of the body that can continue until the drug clears the system. There is no antidote to Xarelto bleeding – which means bleeding will continue as long as the medication remains in the patient’s system. Uncontrolled bleeding is always a concern, but it can be especially dangerous if it occurs near a vital organ, such as the brain, lungs, kidneys, or liver. Symptoms of internal bleeding include:

• Unexplained bruising
• Abnormal liver function
• Reduced platelet levels or other abnormalities in the blood
• Neurological abnormalities
• Sudden or extreme dehydration or fatigue
• Abdominal swelling
• Change in skin color

As a result of the complications related to Xarelto, the FDA ordered the drug’s manufacturer to include a black box warning – the most serious warning available – on the medication. However, the warning only addresses part of the problem. Xarelto’s black box warning includes information about an increased risk of blood clot formation after the medication is discontinued and the increased risk for blood pooling when the medication is prescribed after medical procedures that involve the spine.

Despite the popularity of Xarelto, many are concerned the medication is dangerous and some affected by Xarelto have taken legal action against the drug’s manufacturers. Reports show Bayer faces as many as nine lawsuits regarding Xarelto prescriptions in the United States. One Xarelto lawsuit, filed in the US District Court for the District of Vermont in July 2014, was brought by a victim’s family after the man experienced fatal brain bleeding after using Xarelto for only 10 days.

Other lawsuits claim Bayer and Johnson & Johnson were aware of the bleeding risks related to Xarelto, as well as the lack of antidote to uncontrolled bleeding, but failed to warn doctors and patients. The FDA has received nearly 700 adverse event reports related to Xarelto and more lawsuits are expected to be filed.

Sources:

• http://www.medscape.com/viewarticle/773208