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Pulmonary Embolism Overview
Xeljanz side effects may include pulmonary embolism, a condition involving potentially life-threatening blood clots in the lungs.
Clotting in the deep veins of the legs (also called deep vein thrombosis) can occur for a variety of reasons including age, obesity, clotting disorders, and reduced mobility after surgery or during lengthy travel periods.
If the body does not break up large clots quickly enough, these clots can move up the vena cava, the largest blood vessel in the body. From this vessel, the clots may be carried into the pulmonary arteries in the lungs that carry blood to the lungs from the heart where the blood can be oxygenated.
When a pulmonary artery is blocked by a clot, it is called a pulmonary embolism. Symptoms of a pulmonary embolism may include shortness of breath, chest pain, light headedness, and fainting.
The prognosis of a pulmonary embolism depends on the size of the clot, the number of clots, the effect on blood flow, and overall health. In severe cases, pulmonary emboli can cause sudden death.
The Body’s Clotting Process
Blood in the body naturally clots in response to injury and other processes. Too much clotting can result in blocked blood vessels, but too little blood clotting can result in excessive bleeding internally and from injuries. The body’s goal is to reach a healthy equilibrium.
Hemostasis is the body’s attempt to resolve excessive clotting from blood vessels. This process involves constricting blood vessels, the activity of platelets to help clotting, and the activity of blood clotting proteins in the blood.
Xeljanz Side Effects May Include Pulmonary Embolism
Xeljanz is an oral biologic used to treat autoimmune conditions including rheumatoid arthritis and ulcerative colitis. The drug is part of the drug class of Janus kinase (JAK) inhibitors, and Xeljanz was the first FDA approved medication in this class.
According to the manufacturer, Xeljanz side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).
However, in late February 2019, the U.S. Food and Drug Administration (FDA) released a safety announcement warning that Xeljanz had been linked with pulmonary embolism. An ongoing safety trial, which is set to resolve in late 2019, reportedly showed that individuals taking Xeljanz were at an increased risk of pulmonary embolism.
“During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor,” the FDA safety announcement states.
The trial is ongoing and, after it resolves, the FDA will reportedly update the public with any new information based on their “ongoing review”.
Healthcare professionals are encouraged to monitor their Xeljanz patients for pulmonary embolism and inform their patients of the potential risks. Patients are encouraged to monitor for symptoms of the condition and seek medical attention but are told not to stop taking their medication without medical attention.
