Patients trust their health care providers, especially during times of crisis. When a physician prescribes a medication, we typically fill the prescription and trust that the drug will help us to heal. However, Xarelto, a blood thinner prescribed to millions of people to prevent the dangerous blood clots that cause strokes, is reported to deliver devastating side effects, including damaging or fatal brain hemorrhages. Xarelto blocks thrombin, which is the chemical in your blood that clots blood. The blocking of thrombin prevents clots from forming in patients that are at risk, such as patients who have joint surgery. Bayer and Johnson & Johnson advertise Xarelto as a safe drug that is more convenient than Warfarin, but it also can cause fatal side effects, such as brain hemorrhages.
Xarelto and Brain Hemorrhages
Xarelto was approved by the FDA in 2011 for stroke and as a preventative measure for patients suffering from non-valvular atrial fibrillation. Many benefits have made it many physician’s choice over Warfarin, including its once daily use, lesser need for monitoring and the claim that it has less of a risk for brain hemorrhages. A study conducted by California doctors found that the risk for intracranial hemorrhages increased in patients over the age of 65 who were taking Xarelto. The study also found that Xarelto should not be recommended in patients with decreased creatinine clearance, as the risk for brain hemorrhage is higher.
Xarelto is known to cause intracranial bleeding, or brain hemorrhages, which occur when blood suddenly rushes into the brain tissue and causes damage to the brain. The sudden accumulation of blood puts pressure on the brain and interferes with the oxygen supply. Nerve damage and permanent brain damage can quickly occur. Symptoms of brain hemorrhages include:
- sudden weakness, tingling, or paralysis
- sudden severe headache
- difficulty swallowing
- blurred with vision in one or both eyes
- loss of balance and coordination
- difficulty with language skills (reading, writing, speaking, understanding)
- nausea and vomiting
- sudden sleepiness, lethargy, loss of consciousness
- confusion and delirium
Treatment typically involves immediate surgery to relieve the pressure from the build up of blood and to repair any damaged blood vessels. Long-term treatments and physical therapy are common, but depend on the hemorrhage location and the degree of damage. Various treatments include physical, speech, and occupational therapy. It is almost guaranteed that patients that have suffered from a brain hemorrhage will have some level of permanent disability.
What Does the FDA Say About Xarelto?
Although the Food and Drug Administration (FDA) has issued numerous safety warnings regarding Xarelto and two “black box warnings,” Xarelto, a drug that is known to cause many health complications, has not been banned. A black box warning is the highest level of warning issued by the FDA with respect to a drug. When the FDA issues these warnings, it means that “reasonable evidence” of a hazard exists. Additionally, the FDA identified research misconduct in the Rocket clinical studies upon which the warnings were based, causing further concern. The FDA indicated that the potential for brain hemorrhages exist in patients relying on Xarelto; however, they do not categorize it as a significant risk to warranty a ban.