Lawsuits have been filed by people who took Xarelto and developed severe bleeding in the brain (cerebral hemorrhage). Once bleeding starts, it can be difficult to stop because Xarelto lacks a reversal agent.
Xarelto and Bleeding in the Brain
When patients on a blood-thinning medication start bleeding, doctors must deactivate that medication to allow blood clots to form. Unfortunately, Xarelto lacks an effective reversal agent. Not even dialysis (mechanically cleaning a patient’s blood) can de-activate Xarelto because it binds so tightly to plasma proteins. Other blood-thinners, such as warfarin, can be reversed with a simple dose of Vitamin K.
Percentage of Xarelto Patients who have Brain Bleeding
The ROCKET AF clinical trial involved over 14,000 patients and was the cornerstone study that established Xarelto’s safety compared to warfarin. After the two-year study, researchers concluded that Xarelto was less likely to cause bleeding in the brain than warfarin. They also noted the following adverse events:
- Intracranial hemorrhage occurred in 172 patients (0.68% per year)
- 74% of brain bleeds (n=128) were intracerebral hemorrhage
- Xarelto patients also had subarachnoid hemorrhage, subdural hemorrhage, and extradural hemorrhage
What is a Cerebral Hemorrhage?
Bleeding in the brain, also known as cerebral hemorrhage, is a type of stroke. The complication occurs when blood vessels rupture and spill blood into the brain tissues or spaces between the brain and its protective membrane or skull. This puts pressure on the brain, which can cause coma and death.
Intracranial Bleeding
Intracranial bleeding irritates tissues, causing inflammation and swelling (edema), and it pools in a mass called a hematoma. All of these complications put pressure on the brain, which cuts off the supply of oxygen-rich blood to brain cells. Within minutes, millions of brain cells can die and permanent brain damage occurs.
Complications
Long-term complications may include memory loss, dizziness, headache, anxiety, and problems concentrating. Some patients also suffer from seizures, temporary or permanent weakness, numbness, problems speaking, and more.
Symptoms
- Severe headache
- Confusion
- Slurred speech
- Vision loss
- Weakness on one side of the body
- Problems balancing
- Seizures
- Vomiting
- Lethargy
- Loss of consciousness
- Coma
- Tingling, numbness
Treatment
Emergency brain surgery may be necessary to relieve pressure inside the skull. This may involve drilling a small hole in the skull and draining blood. In some cases, doctors may need to cut a larger hole (called a craniotomy) to remove solid blood clots or large hematomas.
Resources & Additional Information
- Bleeding in the Brain — Healthline
- Management of Intracerebral Hemorrhage — Vasc Health Risk Manag. (Oct 2007)
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