Side Effects of Xeljanz May Increase Risk of Pulmonary Embolism, Death: FDA Warning

Federal health officials indicate that side effects of Xeljanz, a popular rheumatoid arthritis and ulcerative colitis drug, may increase the risk of blood clots in the lungs, potentially resulting in a pulmonary embolism or death.

The FDA’s Xeljanz warning was issued Monday, after a recent clinical trial found that patients taking certain dosage amounts of Xeljanz for rheumatoid arthritis were found to be more likely to develop blood clots or die, when compared to individuals taking the same doses of the drug to treat ulcerative colitis.

Xeljanz (tofacitinib) is a drug that was first approved by the FDA in 2012 to treat adults with rheumatoid arthritis, which is an autoimmune disorder that causes inflammation of the joints in approximately 1% of the population. The drug was designed to block the activity of certain enzymes in the body that affect immune system function and is commonly used as an alternative for patients who have tried methotrexate and other medications without success.

In December of 2017, the FDA approved the use of Xeljanz and Xeljanz XR for the treatment of active psoriatic arthritis (PsA), and then approval was expanded again in May 2018 to include treatment of moderate to severe active ulcerative colitis.

As part of the drugs approval process, the FDA required a post-marketing study to evaluate the safety of the drug in separate doses to assess the risk of cardiovascular events.

After evaluating data from the Xeljanz clinical trial results, the drug manufacturer Pfizer announced Wednesday, February 19, that patients receiving 10mg doses of Xeljanz twice per day were found to have a significantly higher risk of experiencing pulmonary embolisms and had an overall higher rate of mortality when compared to patients taking 5mg doses of Xeljanz for ulcerative colitis.

Additional concerns raised in the clinical trial found patients taking Xeljanz were at an increased risk for developing serious infections including tuberculosis, invasive fungal infections and bacterial and viral infections that resulted in hospitalizations and deaths. Pfizer announced if a patients develops an infection while using Xeljanz, treatment should be interrupted until the infection is controlled.

Pfizer, in conjunction with the FDA, announced they will begin reassessing dosage levels and infection warnings raised during the clinical trial. Healthcare professionals are being encouraged to follow the updated Xeljanz prescribing information and monitor all patients for symptoms of pulmonary embolism.

Patients are being asked to not change their dose of Xeljanz before consulting with their healthcare professional, as doing so could worsen their condition. Patients taking Xeljanz who begin to experience sudden shortness of breath, chest pain, difficulty breathing, coughing up blood, excessive sweating or clammy or bluish colored skin should seek immediate medical help.

Since Xeljanz was first introduced into the market in 2012 by Pfizer Pharmaceutical Company, roughly 1% of the population is anticipated to have used or currently be using the medication. The company’s multi-purpose drug has been steadily increasing in sales each year, with Pfizer reporting revenue increases of 170% last year as revenue of between $53 billion and $55 billion were anticipated for 2018.