Dangerous Drugs

Xeljanz® (Tofacitinib) linked to increased risk of blood clots in the lungs or death during a post-marketing study

January 31, 2020

In early 2019, the FDA released a public safety announcement that alerted the public to alarming side effects found after taking 10 mg doses of Xeljanz, twice a day, for extended periods. While this dosage was only approved for use by patients who suffered from acute UC, records showed that Xeljanz was being prescribed at this dosage for cases of severe RA as well.

Xeljanz is a popular prescription medication that helps treat adults with moderate to severe rheumatoid arthritis (RA). The medication was approved by the FDA in 2012 as an alternative for patients who did not respond well to methotrexate, the only other medication available at that time. Xeljanz works by decreasing the activity of the immune system which helps to slow swelling and decrease pain, particularly in the joints. Xeljanz was also found to help patients with psoriatic arthritis (PsA) and ulcerative colitis (UC). The prescription drug was approved by the FDA in 2017 to treat PsA and in 2018 to treat UC.

Post-marketing study of Xeljanz  

FDA regulations required Pfizer, the manufacturer of the medication, to conduct a safety trial to determine the risk of side effects that may develop after long-term use. As standard protocol for medications approved by the FDA, the research maps the long-term side effects experienced and may reveal any unforeseen issues.

In early 2019, the FDA released a public safety announcement that alerted the public to alarming side effects found after taking 10 mg doses of Xeljanz, twice a day, for extended periods. While this dosage was only approved for use by patients who suffered from acute UC, records showed that Xeljanz was being prescribed at this dosage for cases of severe RA as well.

The research showed that “an increased risk of blood clots in the lungs and [even] death” resulted in some cases of heavily prescribed dosages (10 mg twice a day) of Xeljanz. The blood clots that developed in the lungs, known as pulmonary embolisms, restrict blood flow which in turn decreases oxygen levels in the body. This decrease in oxygen levels can cause irreversible damage to the lungs and other organs. In some extreme cases, pulmonary embolisms can even be fatal.

While the FDA continued to monitor results that came in, they maintained their approval of the medication under the specified dosages. Later in 2019, the FDA released another public announcement that approved a black box warning for Xeljanz and Xeljanz XR due to blood clots developing in patients as well as several deaths from patients taking the medication.

The FDA reported that the results of the study showed that those taking Xeljanz accounted for nearly twice the number of deaths than compared to the Xeljanz alternative, methotrexate (TNF blockers). The study also found that patients taking Xeljanz developed blood clots six and a half times more frequently than those taking TNF blockers.

Janet Woodcock, FDA Center for Drug Evaluation and Research Director, said the agency is taking appropriate steps to ensure the safety of those patients who were involved in the study. “We are communicating now, given the serious nature of the safety issue, to ensure that patients taking Tofacitinib are aware that the FDA still believes the benefits of taking Tofacitinib for its approved uses continue to outweigh the risks.”

Accordingly, you should not change your Xeljanz use unless you have spoken with your doctor. Even so, you should be aware of the following blood clot symptoms that could occur while taking Xeljanz. They include:

-        Sudden shortness of breath or difficulty breathing

-        Chest pain or back pain that worsens with breathing

-        Coughing up blood

-        Excessive sweating

-        Clammy or bluish-colored skin

-        Swelling of a leg or arm

-        Leg pain or tenderness, or red or discolored skin in a painful or swollen leg or arm

If you are experiencing any of these symptoms, seek emergency medical attention immediately.

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