Xeljanz and MACE Injuries
Preliminary results from an FDA-mandated study conducted by Xeljanz and Xeljanz XR’s manufacturer, Pfizer, found that patients taking the popular rheumatoid arthritis medication are at an increased risk of developing serious heart-related injuries.
Xeljanz is also used to treat psoriatic arthritis and ulcerative colitis. The preliminary results of the study were concerning enough to spur the FDA to issue a safety communication warning consumers about an increased risk of major adverse cardiac events (MACE), blood clots, and cancer in patients taking Xeljanz.
What Are MACE Injuries?
Major Adverse Cardiac Events (MACE) injuries include:
- Heart attack (myocardial infarction)
- Cardiac arrest
- Acute coronary syndrome
- Aortic dissection
What Is a Heart Attack (Myocardial Infarction)?
A heart attack occurs when the flow of blood to the heart is blocked. The blockage is usually caused by a buildup of fat, cholesterol, other substances. The substances form a plaque in the arteries that feed blood to the heart (coronary arteries). If the plaque ruptures, a clot can be formed that blocks blood flow to the heart. If blood flow is interrupted, damage or destruction of parts of the heart muscle can occur. The technical term for a heart attack is myocardial infarction.
Heart attacks can be fatal, so it is important to call 911 for emergency medical help if you or a loved one experiences heart attack symptoms. Heart attack symptoms include:
- Pressure, tightness, pain, or squeezing or aching sensation in chest or arms that may spread to neck, jaw or back
- Nausea, indigestion, heartburn or abdominal pain
- Cold sweat
- Lightheadedness or sudden dizziness
What Can Happen If I Suffer a Heart Attack?
According to the Centers for Disease Control and Prevention, the more time that passes after a heart attack without treatment to restore blood flow, the greater the damage to the heart.
Complications from heart attacks are related to the damage caused to the heart muscle during the myocardial infarction. Abnormal heart rhythms (arrhythmias) can occur which are electric “short circuits” that can be serious and may lead to death. If the heart attack damages a substantial amount of heart tissue causing the heart muscle to be unable to pump enough blood out of the heart, heart failure can occur. It can be a temporary or chronic conduct. Sudden cardiac arrest can occur without warning. It involves your heart stopping due to an electrical disturbance causing an abnormal heart rhythm. Heart attacks increase the risk of sudden cardiac risk, which can be fatal without immediate treatment.
What Is Cardiac Arrest?
Sudden cardiac arrest is the abrupt loss of heart function, breathing, and consciousness. The condition is usually caused by problems with the heart’s electrical system–usually an abnormal heart rhythm (arrhythmia). This disrupts the heart’s pumping mechanism and stops blood flow to the body. It is distinct from a heart attack which occurs when blood flow to part of the heart has been blocked. However, a heart attack can sometimes trigger an electrical disturbance leading to sudden cardiac arrest. If sudden cardiac arrest is not treated immediately, it can lead to death.
Symptoms of Sudden Cardiac Arrest include:
- Sudden collapse
- No pulse
- No breathing
- Loss of consciousness
- Chest discomfort
- Shortness of breath
- Fast-beating, fluttering or pounding heart (palpitations)
What Can Happen If I Suffer Cardiac Arrest?
Complications of sudden cardiac arrest are reduced blood flow to the brain which can cause unconsciousness. If the heart rhythm does not quickly return to normal, brain damage and death may occur. Survivors of sudden cardiac arrest may have long-term brain damage.
What Is Acute Coronary Syndrome?
Acute coronary syndrome encompasses a range of conditions associated with the sudden reduction of blood flow to the heart. It is usually caused by the buildup of fatty deposits known as plaques in and on the walls of the arteries in the heart which deliver oxygen and nutrients to the heart muscles. When the plaque ruptures or splits, a blood clot forms which blocks the flow of blood. When the supply of oxygen becomes too low, heart cells can die. The death of cells which result in damage to muscle tissues in the heart is known as a heart attack. Even if the acute coronary syndrome does not cause cell death around the heart, reduced blood flow can change how the heart works and creates a higher risk of heart attacks.
Symptoms of acute coronary syndrome include:
- Chest pain or discomfort
- Pain spreading from chest to shoulders, arms, upper abdomen, back, neck or jaw
- Nausea or vomiting
- Shortness of breath
- Sudden, heavy sweating
- Lightheadedness, dizziness or fainting
- Unusual or unexplained fatigue
- Feeling restless or apprehensive
What Can Happen If I Suffer Acute Coronary Syndrome?
Acute coronary syndrome is a medical emergency requiring immediate treatment. Even with immediate treatment, temporary or long-term damage can occur.
What Is Aortic Dissection?
Aortic dissection is a serious condition where the inner layer of the large blood vessel that branches off from the heart (the aorta) tears. Then blood comes through the tear and causes the inner and middle layers of the aorta to separate (dissect). If there is a rupture outside the aortic wall, aortic dissection can be fatal. Chronic high blood pressure may stress aortic tissue which makes it more susceptible to tearing.
There are two types of aortic dissection: Type A and Type B. Type A is the most common and dangerous type. It involves a tear in the part of the aorta where it exits the heart or occurs in the upper aorta which could extend into the abdomen. Type B involves a tear in the lower aorta which can also extend into the abdomen.
Symptoms of aortic dissection include:
- Sudden severe chest or upper back pain that radiate to neck or down back
- Sudden severe abdominal pain
- Loss of consciousness
- Shortness of breath
- Sudden difficulty speaking, loss of vision, weakness or paralysis of one side of your body, similar to those of a stroke
- Weak pulse in one arm or thigh compared with other
- Leg pain
- Difficulty walking
- Leg paralysis
What Can Happen If I Suffer Aortic Dissection?
Complications from aortic dissection include death from internal bleeding, organ damage such as kidney failure or intestinal damage, stroke, aortic valve damage (aortic regurgitation) or a rupture in the lining around the heart (cardiac tamponade).
How GoldenbergLaw Can Help
If you or a loved one suffered a heart-related injury after taking Xeljanz, contact the team of Xeljanz Attorneys at GoldenbergLaw today for a free consultation. We have over 35 years of defective pharmaceutical litigation experience, let us provide the Gold standard of advocacy you deserve.