Xeljanz Blood Clot Risk Seen With Higher Doses, EMA Warns

European health officials have released a warning about the potential side effects of Xeljanz, agreeing with recent warnings issued by American health regulators about the risk of potentially deadly blood clots linked to the popular rheumatoid arthritis and ulcerative colitis drug.

The European Medicines Agency (EMA) issued a press release on March 20, warning healthcare professionals not to exceed the recommended dose of Xeljanz when treating arthritis, due to increased risk of pulmonary embolism.

According to the EMA, the blood clot risk with Xeljanz comes when the normal dose of 5 mg twice a day is doubled. The warning is similar to one issued by the FDA in the United States in late February.

Xeljanz (tofacitinib) was first approved by the FDA in 2012, to treat adults with rheumatoid arthritis, an autoimmune disorder that causes inflammation of the joints in approximately one percent 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 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. Generally, it is given at the 5 mg per day dose to treat arthritis, and at 10 mg per day to treat ulcerative colitis, according to the EMA warning.

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 last month that patients receiving 10mg doses of Xeljanz twice per day may face a significantly higher risk of experiencing pulmonary embolisms and have 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.

“While full results are awaited, EMA is recommending that healthcare professionals monitor patients for signs and symptoms of blood clots in the lungs,” the EMA warning indicates. “Patients should not stop or change their dose of Xeljanz without talking to their doctor. Patients should seek medical attention immediately if they experience symptoms such as difficulty breathing, pain in the chest or upper back and coughing up blood.”

Since Xeljanz was first introduced into the market by Pfizer Pharmaceutical Company in 2012, 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.