Patients who have taken the drug Xeljanz to treat certain forms of arthritis and ulcerative colitis are learning that the cure could be worse than the disease.
In early February 2021, the United States Food and Drug Administration (FDA) issued an alert to patients, pharmacies, and health professionals warning of serious dangers associated with using Xeljanz. Specifically, the drug has been linked to a greater risk of serious heart problems and cancer when compared with an alternative type of drug, tumor necrosis factor (TNF) inhibitors.
The agency approved labeling Xeljanz with a “black box warning,” the most stringent of FDA warnings, intended to bring awareness to a prescription drug serious or life-threatening risks.
Just two years earlier, in February 2019, the FDA had issued an alert advising that a safety clinical trial showed a heightened risk of blood clots in the lung (and death) when rheumatoid arthritis (RA) patients took a twice-daily 10mg dose of Xeljanz.
Tips for Patients Who Take Xeljanz
The FDA stresses that patients should consult with their health care providers before discontinuing their use of Xeljanz (tofacitinib). If a patient has a history of heart problems or blood clots, it is crucial they inform their doctor of this history. The agency further advises that patients seek immediate medical attention if they experience atypical symptoms after taking Xeljanz.
Symptoms of a blood clot could include sudden shortness of breath and chest pain that becomes worse when the patient breathes. The patient might discover swelling in their arms or legs, and they might feel tenderness, pain, or discolored skin in the affected arms or legs. Excessive sweating and coughing up blood could also be symptomatic of a blood clot in the lungs and demand immediate medical attention.
Suggestions for Health Care Professionals
The FDA urges health care providers to discontinue tofacitinib unless a patient has not responded to or experienced a reaction to TNF blockers. In addition, patients with a heightened risk of thrombosis should not be given Xeljanz, the FDA cautions.
The agency also encourages doctors and patients to report side effects and any adverse events of the drug to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Approved in 2012 for the treatment of rheumatoid arthritis and again in 2018 for the treatment of ulcerative colitis, Xeljanz works by decreasing the activity of overactive immune systems that cause serious inflammation. It has been prescribed to hundreds of thousands of patients, and manufacturer Pfizer reportedly made around $1.7 billion from the drug in 2018.
With the FDA’s strict warnings about the dangers of pulmonary embolism (blood clots in the lungs), serious heart problems, and even death, the legal industry has stepped up, and lawyers are now accepting cases to help patients who have suffered illness or the death of a loved one due to Xeljanz.