It is known that poor circulation causes blood clots, but numerous other factors can be involved – including certain prescription medications, such as Xeljanz.

Recently, the FDA approved a “black box” warning about an elevated risk of blood clots for patients who are taking higher doses of Xeljanz. A black box warning is the most serious kind of alert that the FDA can require in the prescribing information for a given medication. Patients who suffer from a condition that calls for Xeljanz may want to discuss these risks for their prescribing physician.

What is Xeljanz and Why is it Prescribed?

Xeljanz (tofacitinib) is a “janus kinase (JAK) inhibitor,” meaning that it blocks certain molecules that cause inflammation. Xeljanz was originally approved by the FDA in 2012 for the treatment of rheumatoid arthritis in patients who fail to respond to methotrexate, a chemotherapy drug used primarily as an immunosuppressant, or anti-rejection drug.

Initially, the FDA approved a dosage of 5 milligrams twice daily, as it was deemed that the risks of higher doses outweighed the benefits.

Since then, the FDA has granted approval for Xeljanz as a treatment for active psoriatic arthritis and “moderate to severely active” ulcerative colitis.

What is the Difference Between Rheumatoid and Psoriatic Arthritis?

WebMD indicates that Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PA) are both autoimmune diseases in which the person’s immune system attacks healthy tissue as if it were a foreign body. Because of this ongoing attack mode, the tissue which lines the joints suffer, and become chronically swollen and painful, leading to deformity.

When PA is involved, there is an added element. Skin comes under attack as well as the joint tissue and leads to patches of rough scarred skin. Part of the causation involved in this symptom is that the body is tricked into producing more than its normal share of skin cells. Both types of arthritis can ultimately affect the function of organs, eyes, and vessels of the circulatory system.

Both RA and PA have a genetic basis and have been found to develop along family lines. It is rare for sufferers to have both conditions and, more commonly have one or the other. The onset of PA symptoms is in the 30 to 50 age range, whereas the onset of RA symptoms come on a lot later between 40 to 60 years old.

What is Ulcerative Colitis?

According to the Mayo Clinic, ulcerative colitis (UC) is a disease process characterized by chronic inflammation of the body’s bowels. It often comes with a breakout of sores along the length of the digestive tract. A sufferer of the disease may experience unexplained weakness, weight loss, and fever along with gastrointestinal symptoms.

Some of these symptoms include unproductive sudden bowel movement urges, bloody diarrhea, pain associated with gut cramping, and rectal bleeding. UC is incurable, impinges on the patient’s lifestyle, and can threaten the life of the person with complications.

What Are Side Effects of Xeljanz?

More common side effects of Xeljanz are:

• diarrhea
• headache
• hypertension
• respiratory infection
• lymphoma

How Might Xeljanz Cause Blood Clots?

Any medication that causes blood clots might put the patient at risk for a pulmonary embolism, a blood clot that lodges in the lungs. The FDA issued its boxed warning about pulmonary embolism in February 2019 after receiving the results of a safety study indicating that a higher dosage (10 mg., twice a day) caused a significantly higher risk of blood clots in the lungs.

The higher dose was approved for patients with ulcerative colitis, but not those being treated for rheumatoid arthritis. Since the preliminary findings of that study were published, the drug’s manufacturer, Pfizer, has been advising doctors to dial back their patients’ doses to the lower, 5 mg. dose.

The exact mechanism by which Xeljanz may cause blood clots is not fully understood. What is known is that out of an average of 3,800 patient-years of follow-up, there were 19 cases of pulmonary embolism among Xeljanz patients at the 10 mg. dosage as opposed to 3 cases among those who took an alternative medication according to Rheumatology News.

How do I know if I’m at Risk?

Symptoms of pulmonary embolism include:

• respiratory distress or shortness of breath
• pain in the chest and/or back
• a cough that produces blood
• unusually heavy perspiration
• clammy skin and bluish coloring

If you are taking Xeljanz for ulcerative colitis and experience any of the above symptoms, call 911 immediately and get to an emergency room.

If Xeljanz Causes Blood Clots, Should I be Taking it?

It is inadvisable to suddenly stop taking any medication without first discussing it with your prescribing doctor; otherwise, your condition may become worse.

If you are concerned about Xeljanz and pulmonary embolism, share your concerns with your physician; there may be alternative treatments for ulcerative colitis available, including non-steroidal anti-inflammatory drugs (NSAIDs), steroids, analgesics, and dietary supplements.

Learn More

This article is not legal advice. It is presented 
for informational purposes only.