Xarelto Side Effects: Internal Bleeding & Pulmonary Embolism

Since Xarelto was released in 2011, there have been several reports and studies released, thousands of product liability lawsuits filed, and various FDA warnings, about the dangers of Xarelto usage.  Xarelto has been linked to several serious side effects that can cause severe injury and even death.

Why is Xarelto Different From Other Blood Thinners?

Xarelto is different from other blood thinners because it is an Xa inhibitor.  It thins the blood by blocking thrombin, the chemical in the blood that causes the blood to clot.  By blocking thrombin, Xarelto is designed to help break down and prevent clots that can be problematic if an individual has recently undergone a hip or knee replacement surgery, is experiencing deep vein thrombosis, or is diagnosed with atrial fibrillation.

But critics say Xarelto is also more dangerous than other blood thinners because there is no reversal agent that will work with the drug. If a patient is taking Xarelto and experiences internal bleeding, there is no drug available that will help the blood clot and stop the bleeding.  If a patient experiences internal bleeding and is taking Warfarin, on the other hand, a doctor can administer vitamin K or promatine sulfate and the blood will begin to clot again.

What Are The Side Effects?

The most severe side effect that has been linked to Xarelto usage is uncontrollable internal bleeding.  Internal bleeding is much more dangerous than external bleeding because it is much more difficult to identify.  Since Xarelto keeps the blood from clotting, an internal bleeding event can result in a need for urgent hospitalization or even in death.

In addition to severe internal bleeding, one of the serious risks that has been linked to Xarelto usage is that it can cause blood clots if the individual stops taking the drug prematurely.  This has been reported happening when patients are transitioning from Xarelto because it has no reversal agent, back to Warfarin, which has a reversal agent.

FDA Reports On Risks

In 2013, the FDA released a report focused on the adverse medical events linked with Xarelto usage.  The report stated that 2,100 of the people surveyed reported an adverse event concerning Xarelto.  1,821 of those individuals cited Xarelto as the primary cause of the event.

The top four side effects reported in this study were:

• pulmonary embolism,
• deep vein thrombosis,
• gastrointestinal bleeds and
• hemorrhages.

Other adverse events reported include thrombosis, cerebrovascular incidents, dyspnea, edema, hemoglobin deficiency, and hematoma.  In 891 of the cases reported, hospitalization was required and unfortunately, 183 cases reported the death of the patient.

Pulmonary Embolism & Deep Vein Thrombosis

A pulmonary embolism occurs when the blood flow to the lungs is blocked because of a blood clot.  A pulmonary embolism is most commonly caused by deep vein thrombosis, which is when a blood clot is formed in the deep veins of the arms or legs, then it travels to the lungs where it causes a blockage.  Symptoms of a pulmonary embolism include coughing up blood, severe chest pain, and a shortness of breath, but these symptoms may only occur after serious damage has already been done.  A pulmonary embolism can cause the body to begin to shut down since the supply of blood to the lungs is cut off, preventing the body from processing oxygen.  Pulmonary embolisms are very difficult to diagnose and often lead to death.

Gastrointestinal Bleeds

Internal bleeding in the abdominal area can be very serious.  The abdominal area houses a high concentration of vital organs and in the event of an internal bleed, blood can pool around these organs and cut them off from their supply of freshly oxygenated blood.  If the organs are cut off from oxygen for too long they will begin to die.  Signs of a gastrointestinal bleed include coughing up or vomiting up blood and vomiting blood that resembles coffee grounds.

Brain Bleeds

Any type of internal bleeding in the brain is very dangerous.  Internal bleeding in the brain can suffocate brain cells and starve them of oxygen.  If they’re cut off from their oxygen supply for too long they will begin to die and the effects will seem like a stroke.  The signs of a brain bleed can be numbness in the face, arm, or legs, slurred speech, difficulty walking or moving, excruciating headaches, impaired vision, and lack of coordination.

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