Treatment for Xeljanz Injuries

Popular rheumatoid arthritis, psoriatic arthritis, and ulcerative medication Xeljanz has been potentially linked to MACE injuries, strokes, and blood clots through a clinical study. These injuries require extensive treatment. 

Read our Xeljanz Safety Evaluation Timeline for additional information on the approval history of Xeljanz and the study that has potentially connected the popular medication Xeljanz to strokes, blood clots, and MACE injuries such as heart attacks and cardiac arrests. 

For additional information on the Xeljanz lawsuits, see our Xeljanz Area of Practice page.

Treatment for MACE Injuries

Major Adverse Cardiac Events (MACE) injuries include: 

  • Heart attack (myocardial infarction) 
  • Cardiac arrest
  • Acute coronary syndrome 
  • Aortic dissection 

Treatment for Heart Attacks

Treatment for a heart attack can include

  • Cardiac catheterization
  • Angioplasty 
  • Stent placement 
  • Heart bypass surgery 
  • Heart valve surgery 
  • Pacemaker placement
  • Heart transplant

Cardiac catheterization

Cardiac catheterization involves a probe being inserted into the blood vessel through a soft flexible tube known as a catheter. This allows the doctor to find the plaque buildup. The doctor may also inject dye into arteries through the catheter and take an X-ray to see how the blood is flowing and determine if there are any blockages. 

Angioplasty 

An angioplasty procedure opens up the blocked artery by using a balloon attached to a catheter or by removing a plaque buildup. 

Stent Placement 

A stent is a wire mesh tube that is inserted into the artery to keep it open after an angioplasty procedure. 

Heart Bypass Surgery 

In a heart bypass surgery, a doctor will reroute your blood flow around the blockage to restore heart function. 

Heart Valve Surgery 

During heart valve surgery, leaky valves are replaced to aid the heart in pumping blood. 

Pacemaker Placement 

A pacemaker is implanted beneath the skin and is designed to help the heart maintain a normal rhythm. 

Heart Transplant 

A heart transplant may be performed in severe cases when the heart attack has caused permanent tissue death to the majority of the heart.

Treatment for Cardiac Arrest

Emergency treatment for sudden cardiac arrest includes cardiopulmonary resuscitation (CPR) using a defibrillator or chest compressions to maintain blood flow which provides oxygen to the body. Using a defibrillator will deliver an electrical shock to the heart which momentarily stops the heart and often facilitates the return of the normal heart rhythm.

Long-term treatment for cardiac arrest can include medications such as antiarrhythmic drugs known as beta blockers or angiotensin-converting enzyme (ACE) inhibitors and channel blockers intended to reduce the risk of cardiac arrest. 

A doctor may also insert an implantable cardioverter-defibrillator (ICD) which is a battery-powered unit placed into the body near the left collarbone. There are one or more electrode-tipped wires from the unit that run through veins to the heart to constantly monitor its rhythm. If the rhythm becomes too slow, the unit paces your heart as a pacemaker would. If it detects a dangerous rhythm change, it sends out a low or high energy shock to reset the heart to a normal rhythm. 

A coronary angioplasty procedure can open the blocked coronary arteries which allows blood to flow more freely to the heart. The procedure is intended to reduce risk of serious arrhythmia. It involves a thin tube being passed through an artery (usually in the leg) all the way to the blocked artery in the heart. A catheter equipped with a special balloon tip briefly inflates to open the blocked artery. At the same time, a metal mesh stent may be inserted into the artery to keep it open long-term to restore blood flow to the heart. This procedure can be done at the same time as coronary catheterization. 

Cardiac bypass surgery is a procedure that involves coronary artery bypass grafting. This means that veins or arteries are sewed away from the blocked or narrowed heart artery which restores blood flow to the heart and reduces the frequency of racing heartbeats. 

Radiofrequency catheter ablation is also an option which is used to block a single abnormal electrical pathway. One or more catheters is moved through the blood vessels to the heart and is positioned along the electrical pathways that are causing the abnormal heart rate. The electrodes on the catheter tips are heated with radiofrequency energy to heat the tissue at the site of the arrhythmia in order to destroy it. 

Corrective heart surgery is also an alternative if a patient has a congenital heart deformity, a faulty heart valve, or diseased muscle tissue due to cardiomyopathy. The surgery to correct the abnormality can improve heart rate and blood flow which reduces risk of abnormal heart rates. 

Treatment for Acute Coronary Syndrome

Treatment usually involves medications and an angioplasty procedure. The procedure involves doctors inflating a small balloon attached to a catheter to open the blocked artery. A stent (wire mesh tube) may be permanently placed in the formerly blocked artery to keep it open. A coronary bypass surgery may also be used to reroute the blood flow. The surgeon takes a piece of blood vessel (graft) from another part of the body to create a new route for the blood to flow around the blocked artery. 

Medications are also used to dissolve blood clots. These medications include thrombolytics (clot busters) which dissolve a blood clot by temporarily widening blood vessels, antiplatelet drugs to prevent future blood clots from forming, beta blockers to relax the heart muscle and slow the heart rate, angiotensin-converting enzyme (ACE) inhibitors to widen blood vessels and improve blood flow, and angiotensin receptor blockers (ARBs) to help control blood pressure. 

Treatment for Aortic Dissection

Aortic dissection can be treated by medication, surgery, and other endovascular treatments. Depending on how much of the aorta is torn, repair may require open heart surgery which involves replacing the aorta with a fabric tube called a graft. Surgeons can also use stent grafts (fabric tube supported by metal wire stents) to repair the existing aorta. Stent grafts are placed into the patient endovascularly which means they are placed over a wire through a small incision in the groin, delivered upstream into the aorta, and then release stents like a spring. There are also hybrid procedures that combine open heart surgery with endovascular stent grafting techniques. Additionally, medications such as beta blockers are prescribed to lower a patient’s heart rate and blood pressure. 

For Type A aortic dissection, surgeons remove as much of the dissected aorta as possible, block the blood from entering the aortic wall, and then reconstruct the aorta with a graft. Leaking aortic valves can also be replaced at this time. 

For Type B aortic dissection, surgeons use similar techniques to those used to treat Type A, but they may also involve stents to act as scaffolding in the aorta to hold up the repairs. 

After all types of aortic dissection treatments, patients will likely need to take medications to lower their blood pressure for the remainder of their lives. 

For more information about MACE injuries connected to Xeljanz, read our Xeljanz Injuries: Major Adverse Cardiac Events blog. 

Treatment for Strokes

Treatment for ischemic strokes focuses on restoring blood flow to the brain. It usually begins with taking drugs to break down blood clots and prevent others from forming. Medical professionals may administer blood thinners such as aspirin or inject a tissue plasminogen activator (TPA). An emergency procedure may include administering a TPA directly into an artery in the brain or using a catheter to physically remove the blood clot. 

Other procedures include a carotid endarterectomy which involves opening the carotid artery and removing the plaque that could break off and travel to the brain. Another procedure is an angioplasty in which a surgeon inflates a small balloon inside the narrowed artery using a catheter. Then a mesh tube (stent) is inserted into the opening to prevent the artery from narrowing again. 

Treatment for a hemorrhagic stroke involves controlling the bleeding and reducing pressure on the brain. It usually starts with taking medication to reduce the pressure and control the overall blood pressure. The treatment is also aimed at preventing seizures and any sudden constrictions of blood vessels. 

If a patient is taking blood-thinning medications such as anticoagulants or antiplatelets, they can receive medications to counter the effects of the blood thinners to decrease the bleeding. 

Otherwise, surgeons can repair the bulge in the blood vessel that burst (aneurysm) by placing small clamps at the base of the aneurysm or fill it with detachable coils to stop the blood flow and shrink the aneurysm.

If a patient has had an ischemic stroke or a TIA, the doctor may recommend preventative medications such as antiplatelet and anticoagulant drugs. Antiplatelet drugs make the platelet cells in the blood less sticky and less likely to clot. The most common antiplatelet drug is aspirin. Anticoagulant medications are given to reduce blood clotting. 

Rehabilitation treatment for strokes includes speech therapy, physical therapy, occupational therapy, support groups, and psychological treatment. Speech therapy helps patients with difficulties speaking or understanding speech by practicing, relaxing the patient, and changing their communication style to make the process easier. Physical therapy helps a person relearn movements and coordination in addition to staying active.  Occupational therapy helps patients carry out daily activities such as bathing, cooking, dressing, eating, reading, and writing. Support groups and psychological treatment help patients deal with the mental health issues that can occur after a stroke–such as depression–through counseling and/or antidepressant medications.

Treatment for Blood Clots

Treatment for blood clots range from medication to surgery. Medications can include blood thinning medications such as anticoagulants. These medications stop the blood clots from growing and allow the body to break down the blood clots naturally. 

Surgical procedures to remove blood clots include catheter-directed thrombolysis procedures. These procedures involve a specialist directing a long tube (a catheter) to the blood clot. The catheter delivers the medication directly to the blood clot to help it dissolve. In thrombectomy surgeries, doctors use special instruments to carefully remove the blood clot and may insert a stent to keep the blood vessel, artery, or vein open. If a patient is unable to take blood thinners, a filter may be put into the inferior vena cava (the body’s largest vein) to catch blood clots before they can travel to internal organs. 

Compression stockings are also used as treatment. The tight-fitting socks apply pressure to help reduce leg swelling and prevent more blood clots from forming. 

Treatment depends on where the clot formed in the body, how much damage the blood clot could cause, and how dangerous it would be to remove the blood clot. 

The goal in treating blood clots (especially those formed with DVTs) is to prevent blood clots from getting larger or breaking loose. Effective treatment can reduce an individual’s chances of developing more blood clots in the future. 

For more information about increased risk of blood clots and strokes connected to Xeljanz, read our Xeljanz Stroke and Blood Clot Injuries blog.

How GoldenbergLaw Can Help

If you or a loved one have been injured after taking Xeljanz, contact the Dangerous Drug Attorneys at GoldenbergLaw. Our team has over thirty years of experience providing the Gold standard of advocacy. Leave the sleepless nights to us!

FDA Xeljanz Safety Evaluation Timeline

What is Xeljanz?

Xeljanz is a medication intended to treat moderate-to-severe forms of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is an immunosuppressant with the active ingredient tofacitinib and is part of the class of drugs known as Janus kinase (JAK) inhibitors.

How Does Xeljanz Work?

Xeljanz works by decreasing a substance called cytokines. Cytokines are proteins that help control the immune system. People with rheumatoid arthritis make more cytokines than needed, which leads to inflammation and pain. Xeljanz disrupts cell signals in the Janus kinase (JAK) pathways to decrease the production of cytokines.

Background on Xeljanz

The U.S. Food and Drug Administration (FDA) approved the medication in 2012 for rheumatoid arthritis patients who were not responding to other medications on the market at the time. In 2017, the FDA expanded its approval of Xeljanz and allowed the drug to be prescribed to patients with psoriatic arthritis, a condition that causes joint swelling or pain. The FDA expanded its approval once again in 2018 to treat ulcerative colitis. 

Despite the FDA’s continued approval, however, the FDA had lingering concerns about Xeljanz and ordered a phase IV, post-market study to be conducted by Xeljanz’s manufacturer, Pfizer.

FDA Xeljanz Clinical Safety Study

The FDA’s study began in March 2014 and recently concluded. It included patients with active moderate-to-severe rheumatoid arthritis who were 50 years or older and had at least one cardiovascular risk factor. 

The final results have not been published publicly. However, preliminary data shows that rheumatoid arthritis patients have up to six times the risk of developing a pulmonary embolism when taking the drug’s 10mg dose twice a day compared to patients taking another medication. Patients taking the 5mg twice daily dose have approximately three times the risk of pulmonary embolism.

Pulmonary embolisms are dangerous blood clots that travel to the lungs. Those who suffer from pulmonary embolisms may have an irregular heartbeat, experience chest pain and trouble breathing, feel faint or lightheaded, cough up blood, and experience pain, swelling, tenderness, and redness in parts of the body where the blood formed or traveled. These blood clots can be life-threatening, and those suffering from pulmonary embolisms should seek immediate medical attention. 

The FDA announced that it will continue to review the study’s results and communicate its final conclusions and recommendations in the future.

Xeljanz FDA Safety Clinical Trial Timeline

February 25, 2019: The FDA found that patients taking a dose of 10mg of Xeljanz twice daily may experience an increased risk of developing blood clots in the lungs and therefore issued a safety announcement. Participants in the study were all over 50 years old and each had at least one cardiovascular risk factor. The participants were taking either the 5mg twice daily dose or the 10mg twice daily dose of Xeljanz and were then compared to a similar group of participants on a tumor necrosis factor (TNF) inhibitor. Three days after the safety announcement from the FDA alerting the public to the increased risk of pulmonary embolism and death, Xeljanz’s manufacturer, Pfizer, sent a letter advising healthcare providers of the same risks. 

July 26, 2019: The FDA issued a Black Box Warning for the 10mg twice daily dose of Xeljanz. The black box warning focused on the increased risk of blood clots and death in people with rheumatoid arthritis over 50 years old with at least one cardiovascular risk factor. The black box warning limited the use of the 10mg twice daily dose of Xeljanz to treating ulcerative colitis patients whose condition was not already being sufficiently managed by other medications. As a result, the FDA discontinued the evaluation of the 10mg twice daily dose of Xeljanz in the ongoing clinical trial and switched the participants to the 5mg twice daily dose. 

February 4, 2021: The FDA issued a safety communication warning the public about the initial results from the ongoing Xeljanz study. The initial results found that there is an increased risk of heart-related problems and cancer in patients taking Xeljanz. The trial compared patients taking the 5mg twice daily and 10mg twice daily doses of Xeljanz to patients taking a tumor necrosis factor (TNF) inhibitor. The participants were all over age 50 and had at least one cardiovascular risk factor. Full results from the clinical trial are not yet available. However, the FDA is recommending that patients continue taking Xeljanz as they were prescribed by their physicians but also to consult their healthcare providers if they have questions or concerns.

How GoldenbergLaw Can Help

If you or a loved one suffered harm after taking Xeljanz, contact the Minnesota Xeljanz Attorneys at GoldenbergLaw today for a free consultation. We have provided Gold standard advocacy for more than 30 years! Contact us today, and you can leave the sleepless nights to us!