A growing number of lawsuits have been filed by people who used Xarelto and developed severe gastrointestinal bleeding. Drug-makers are accused of downplaying the risk of uncontrollable bleeding from Xarelto.
What is the problem?
Gastrointestinal bleeding is one of the most common side effects of Xarelto. The problem is that when Xarelto was approved in 2011, it had no reversal agent. When patients start bleeding, doctors may struggle to deactivate Xarelto so the patient can form life-saving blood clots. It was not until late 2015 that Portola Pharmaceuticals discovered a reversal agent called andexanet alfa.
Kentucky Woman Files Gastrointestinal Bleeding Lawsuit
In February 2014, Bayer and Johnson & Johnson were hit with a lawsuit from a woman from Kentucky who nearly died from gastrointestinal bleeding after taking Xarelto.
She says she started taking Xarelto to treat atrial fibrillation in July 2012. In February 2013, she was hospitalized with gastrointestinal bleeding that doctors struggled to stop. The lawsuit was filed in the Philadelphia Court of Common Pleas. According to the complaint:
“Defendants concealed their knowledge that Xarelto can cause life threatening, irreversible bleeds … Defendants did not properly warn of the irreversible nature of Xarelto in the ‘Warnings and Precautions’ section of the products warning label.”
What is the Risk of Gastrointestinal Bleeding?
When Xarelto was approved in 2011, its safety was established in the ROCKET AF clinical trial. This study found that gastrointestinal bleeding occurred in 3.1% of Xarelto patients, vs. 2% of warfarin patients. Unfortunately, results of the study were based on defective INR-testing devices, which may have skewed results in favor of Xarelto.
Study Finds Xarelto Doubles Risk of Gastrointestinal Bleeding
In April 2015, a study published in the British Medical Journal concluded that patients on Xarelto were twice as likely to suffer gastrointestinal bleeding compared to patients on warfarin. conclusions were based on data from nearly 50,000 people in the United States on blood-thinning drugs from 2010-2012.
What is Gastrointestinal Bleeding?
Gastrointestinal (GI) bleeding can occur at any point in the digestive tract, including the esophagus, stomach, upper intestine, lower intestine (colon), bowel, rectum, and anus.
Diagnosis & Management
There are many sophisticated diagnostic tools a doctor can use to locate the source of a gastrointestinal bleed. You may need to undergo a colonoscopy or a procedure using an endoscope, which involves a small camera with a light on the end. Patients on Xarelto may need to stop the medication while under observation in a hospital until the bleeding stops. Blood transfusions may also be necessary in severe cases.
Symptoms of GI Bleeding
Signs of bleeding in the upper digestive tract:
- Blood in vomit
- Vomit that looks like coffee grounds
- Black, tarry stools
- Dark blood mixed with stool
- Abdominal pain
Signs of bleeding in the lower digestive tract:
- Stools are black or tarry
- Dark blood mixed with stool
- Stool mixed or coated with bright red blood
If the bleeding is severe, patients may develop symptoms of hypovolemic shock, including weakness, light-headedness, shortness of breath, low blood pressure, low body temperature, and more. When the body loses too much blood, major organs begin to shut down. The condition can be fatal.
Resources & Additional Information
- Gastrointestinal Bleeding — NYU Langone Medical Center
- Practical Management of Bleeding due to Xarelto — Cleveland Clinic Journal of Medicine (2013)