A growing number of people have been injured or died from severe, uncontrollable bleeding after taking the blood-thinner Eliquis. When it hit the market in 2013, Eliquis was promoted as superior to warfarin. However, unlike warfarin, it has no reversal agent to stop bleeding in an emergency.
Normally, blood clots are formed when platelets (red blood cells) stick together and plug an injured blood vessel. They stick together with proteins, such as Factor Xa, which Eliquis blocks. Blood clots prevent blood from escaping an injured blood vessel so the body can heal. In some cases, blood clots cause heart attacks and strokes. However, an inability to form blood clots can result in excessive bleeding.
Blood-Thinners and Bleeding
Blood-thinning drugs save lives by preventing harmful blood clots from forming in the body and causing strokes and heart attacks. They don’t actually “thin” the blood. Instead, they change blood chemistry to make it harder for blood clots to form. Patients bleed more easily and it is harder to stop bleeding because they can’t make clots. It is common for patients on blood-thinners to experience bleeding gums, hemorrhoids, nosebleeds, and more.
Eliquis and Bleeding
Eliquis (apixaban) belongs to a new class of blood-thinning medications that have only been on the market for a few years. Unfortunately, it has already been linked to a number of adverse events and deaths from uncontrollable bleeding. Bleeding is the most serious side effect of all blood-thinners, and Eliquis is no exception. However, stopping bleeding in a patient on Eliquis presents unique challenges for an emergency physician.
Bleeding on Eliquis vs. Warfarin
For over 50 years before Eliquis hit the market, most patients were prescribed warfarin. Treatment with warfarin presents its own challenges, but one important advantage is that it can be reversed with a dose of Vitamin K. Eliquis cannot be deactivated with Vitamin K, unlike warfarin. Not even dialysis (mechanically cleaning a patient’s blood) can remove Eliquis from a patient’s body.
What’s the problem?
You may have seen ads for Eliquis claiming it has “less major bleeding” than warfarin. What these ads do not explain is the outcome for patients who do start bleeding. In an emergency, before an unexpected surgery, or after a serious injury, doctors must deactivate any blood-thinners in a patient’s body as fast as possible. The longer the patient bleeds uncontrollably, the higher the risk of complications, including organ failure, brain damage, and death.
Thousands of lawsuits (PDF) have been filed by people who experienced severe bleeding after taking blood-thinning drugs like Pradaxa and Xarelto. Now, a growing number of complaints are being filed by people injured by Eliquis. All of the lawsuits accuse drug-makers of downplaying the risk of bleeding to promote new drugs as superior to warfarin. In July 2015, a wrongful death lawsuit was filed in New York by the widow of a man who bled to death after taking Eliquis.
Eliquis and Bleeding: “No Antidote and Little Clinical Experience”
Prescrire International has recently published a study in which researchers warned: “There is no antidote for [Eliquis], nor any specific treatment with proven efficacy for severe bleeding.” The researchers also questioned whether the risk of uncontrollable bleeding was worth the potential benefits:
“In early 2013, difficulties in the management of bleeding and of situations in which there is a risk of bleeding weigh heavily in the balance of potential harm versus potential benefit of [Eliquis]. When an oral anticoagulant is required, it is best to choose warfarin.”
Bleeding in the Brain
Many patients on Eliquis are older and at risk of falling, hitting their head, and suffering a cerebral hemorrhage (bleeding in the brain). It occurs when a burst blood vessel causes blood to accumulate inside the skull, which puts pressure on the brain and causes brain damage. Symptoms include headache, weakness, confusion, and paralysis, particularly on one side of the body.
One complication of severe bleeding is hypovolemic shock, also known as hemorrhagic shock. It occurs when there is not enough blood in the body because at least 20% has been lost.
During shock, the heart is unable to supply organs with blood they need to survive. Body temperature and blood pressure drop very rapidly. This cuts off circulation to vital organs, which causes them to stop working.
Patients in shock will typically have shallow breathing, unconsciousness, and a pulse that is rapid but weak. Without treatment, it can cause the following complications:
- Kidney damage
- Brain damage
- Gangrene of arms or legs, sometimes leading to amputation
- Heart attack
- Other organ damage
When to Seek Medical Care
If you suspect that someone is going into shock, call 911 immediately. In the meantime, have them lay down flat on the ground and elevate their feet 12 inches off the ground (unless they have an injury). Keep them warm and comfortable, but do not give fluids by mouth.
Get emergency medical attention if you or someone you know has the following symptoms:
- Bleeding that does not stop
- Heavy bleeding
- Bad fall or head injury
- Serious headache, confusion, weakness, or numbness
- Coughing up blood
- Vomiting blood (may look like coffee grounds)
- Menstrual bleeding that is very heavy or lasts longer than normal
- Urine is red or brown
- Bowel movements are red or black and tarry
- Frequent nosebleeds
- Gums (mouth) bleeding that is heavy
- Unusual bruising, swelling, or discomfort
- Severe stomach pain