Blood Clot Problems from Xeljanz Draw Updated EMA Warning for High Risk Patients

European regulators have issued updated warnings about the potential side effects of Xeljanz, indicating doctors should exercise caution when prescribing the rheumatoid arthritis drug to individuals at risk of developing blood clots.

The European Medicines Agency (EMA) issued the Xeljanz warning (PDF) on October 31, following a review by it’s safety committee (PRAC), which determined that Xeljanz can increase the risk of pulmonary embolism and deep vein thrombosis among individuals who are already at risk for those potentially deadly blood clot problems.

Xeljanz (tofacitinib) was first approved in the U.S. 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.

Use of the medication was expanded in December 2017, after the FDA authorized 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.

Both the EMA and FDA now recommend the 10 mg dose not be used in patients with ulcerative colitis, unless there is no suitable alternative. The EMA is now also recommending the same restriction for patients older than 65.

The labels in European versions of Xeljanz will now include new warnings and recommendations, which are based on an ongoing study.

After evaluating preliminary data from a Xeljanz clinical trial released in February 2019, the drug manufacturer Pfizer announced earlier this year 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.

The FDA issued a warning about the Xeljanz blood clot problems after the initial Pfizer results were released in February 2019, but took no action at the time to require new warnings. However, in May, the EMA issued recommendations to doctors, calling for them not to prescribe Xeljanz in its 10 mg, twice-daily dose to patients already at a risk of pulmonary embolism. This latest warning expands that recommendation to all patients at high risk of blood clots.

The FDA issued similar recommendations, including a black box label warning, in July.

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, reaching blockbuster status with sales in excess of $1 billion per year.

Pfizer now faces a number of Xeljanz lawsuits brought by individuals who suffered a pulmonary embolism, deep vein thrombosis (DVT) or other blood clot problems. alleging that the drug maker withheld known risk information from users and the medical community.