Bleeding associated with the use of Eliquis most commonly results in intracranial (within the skull) bleeding (also called a hemorrhagic stroke), or gastrointestinal (GI) bleeding. Other bleeding events occurred at surgical or wound/incision sites in patients taking Eliquis following hip or knee replacement surgeries.

Without an established way to reverse bleeding in patients taking Eliquis, effects should be expected to persist for at least 24 hours after the last dose of the medication is administered.

Patients who stop taking the drug prematurely are also at an increased risk of blood clots and other thrombotic events, such as stroke, while patients who undergo certain spinal or epidural procedures can develop hematomas that can result in long-term or permanent disability and death.

When a patient stops taking Eliquis prematurely, or suddenly, they are at an increased risk of developing blood clots, according to a black box warning contained in drug labeling for the drug.

Typically, a blood clot forms to stop bleeding when a blood vessel is injured. After the bleeding stops, and the area of the body where the bleed occurred is healed, the body breaks down and removes the clot naturally. But when the blood clots too much or abnormally, or when certain conditions prevent the body from dissolving blood clots properly, blood clotting can become excessive and dangerous.

Clots can occur in veins or arteries, which are both blood vessels that make up the body’s circulatory system. Both veins and arteries help move blood in the body, but they each function differently.

Veins are low-pressure vessels that carry blood without oxygen away from the body’s organs back to the heart. When a clot forms within a vein, it can block the blood from returning to the heart, causing pain and swelling as the blood accumulates behind the clot.

Contrarily, arteries are high-pressure vessels that carry oxygen-rich blood from the heart to the body’s organs and tissues. A patient’s blood pressure is a measure of the pressure in the body’s arteries. Clotting that occurs in an artery usually results from the hardening (plaque build-up) of the artery. As the artery narrows, blood continues to be forced through the opening, potentially resulting in a rupture of the plaque. This rupture can spur the formation of a blood clot, which can lead to a blockage of blood supply to the heart (heart attack) or brain (stroke).

Deep vein thrombosis (DVT) results when a clot forms in a deep vein in a limb, usually affecting the deep veins in the legs. Although less common, DVT can also occur in the arms, pelvis or other large veins in the body.

DVT affects approximately 900,000 people in the U.S. each year, and results in up to 100,000 deaths, according to the American Society of Hematology.

A serious complication of DVT is a pulmonary embolism (PE), which is a sudden blockage in an artery of the lung. When a blood clot in a deep vein breaks loose and travels through the bloodstream to the lung, it results in PE and a serious, potentially life-threatening condition requiring emergency medical attention.

About half of individuals suffering from PE have no symptoms. When symptoms are present, they might include shortness of breath, chest pain or coughing up blood.

A blood clot can form in, or travel to, any region of the body, including the lungs, heart or brain, as well as other organs important to the body’s essential functions. Serious complications can occur when a clot interferes with normal blood flow to the body’s organs.

A heart attack occurs when blood flow to the heart is blocked suddenly preventing oxygen from reaching the vital organ. Heart muscle will begin to die without immediate treatment. Heart attacks affect nearly 800,000 individuals in the U.S. each year, according to the National Institutes of Health (NIH).

Strokes occur when blood flow to the brain is interrupted. Brain cells begin to die within minutes. A stroke is a medical emergency.

Blood clots that form in or travel to the kidneys can cause damage that can eventually lead to kidney failure. High blood pressure is just one the complications that can result when fluids and waste build-up in the kidneys. Treatment is needed to do the work the kidneys can no longer do. If not treated properly, kidney failure can potentially result in a coma, seizures or death.

Blood clots that form during pregnancy usually affect the veins in the pelvic region or the legs. This puts pregnant women at an increased risk for PE. Other complications that can result from blood clots during pregnancy include premature labor, miscarriage – loss of pregnancy or death of the mother and potentially the fetus.

Treatment involves breaking up the clots and preventing new clots from forming. This can be done with certain medicines administered orally or via a catheter surgically inserted to deliver medication directly to the site of the clot to help it dissolve. Sometimes surgery is performed to remove a clot. This is called a thrombectomy.

Patients are sometimes referred to a hematologist for treatment. A hematologist is a doctor who specializes in treating blood diseases. Patients who are at risk of arterial clots may also see a cardiologist (a doctor who specializes in conditions affecting the heart) or a neurologist (a doctor who specializes in treating disorders of the nervous system, including diseases of the brain).

Patients who receive neuraxial anesthesia or that undergo spinal puncture while taking Eliquis, are at risk of developing an epidural or spinal hematoma. These hematomas can result in long-term or permanent paralysis, according to drug labeling containing a black box warning for Eliquis.

Optimal timing between taking Eliquis and undergoing a neuraxial procedure is unknown.

Signs and symptoms of neurological impairment occur in the nervous system, which consists of two parts, the central nervous system (CNS) and the peripheral nervous system (PNS). The CNS includes the brain and the spinal cord, and acts as a central processing station. The PNS sends information received by the senses between the muscles, tissues and nerves in the body to the brain. When connections, or messages, are interrupted in the CNS or PNS, then neurological symptoms can occur.

Neurological symptoms can also be accompanied by other systems depending on the underlying cause, disease, disorder or condition affecting the neurological systems. Signs and symptoms of a neurological problem can vary because the nervous system participates in and controls a number of functions and body systems, such as body temperature, blood pressure, muscles, digestion and appetite, movement, and sight.

Neurological symptoms can sometimes occur along with symptoms related to the digestive system. These may include chewing difficulties, digestive problems and boss of bladder or bowel control. Nausea with or without vomiting may be possible.

Signs that a neurological condition may be serious or life-threatening include changes in pupil size or pupils that are nonresponsive to light. Other signs include changes in consciousness or alertness. Disorientation, dizziness and garbled speech are also warning signs. Other indicators include loss of muscle coordination, respiratory problems, seizures and sudden paralysis.

Treatment of a spinal or epidural hematoma will depend on the severity of the condition and the patient’s individual symptoms. Treatment can also be affected if a patient has other health conditions.

Immediate surgical drainage is usually needed to reduce pressure on the brain and the spinal cord.

If not treated timely or properly, a spinal or epidural hematoma can be deadly. While it is possible to recover fully from the condition, hematomas of this nature can often result in permanent damage to the brain and long-term disability.