Dangerous Drug Warning: Arthritis and Ulcerative Colitis Drug Linked to Stroke and Death

What is Xeljanz/Xeljanz XR and has it been linked to death?

Xeljanz (tofacitinib) and Xeljanz XR (tofacitinib citrate) are medications prescribed for patients suffering from Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ulcerative Colitis (UC). The FDA has issued a black box warning (the highest level of warning the FDA can issue) after a safety trial found an increased risk of blood clots in the lungs and death for patients prescribed a dose of 10 mg twice daily. The FDA has ruled that the 10 mg twice daily dosage be limited to certain UC patients who are not receiving an effective treatment or who experience extreme side effects on other medications and is not to be used for RA or PsA patients. The drug manufacturing company, Pfizer, is recommending RA patients be transitioned to the currently approved, lower dosage of 5 mg twice a day.

How does Xeljanz work? 

Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and UC, where the immune system malfunctions and attacks the joints or digestive tract. Xeljanz was first approved in 2012 to treat adults with RA who did not respond well to methotrexate. In 2017, the FDA further approved Xeljanz to cover patients with PsA who did not respond well to the originally prescribed medication, methotrexate, or similar medications. In 2018, the drug was approved to cover UC, which is a chronic, inflammatory disease that affects the colon.

What’s a Black Box Warning?

A black box warning is the strongest safety warning required by the FDA. Designed to call attention to a life-threatening risk, the warning is required to be placed in a box and bolded so that patients and medical providers will pay special attention to the warning. Pfizer is now required to include the following information on its labeling and patient medication guides.

How did the FDA discover Xeljanz's increased risk of blood clots and death?

The FDA has a currently ongoing clinical safety trial for the medications Xeljanz and Xeljanz XR. As of January of 2019, the FDA has identified the following: 19 cases of blood clots in the lungs for patients receiving 10 mg twice daily and 45 cases of death for those prescribed 10 mg twice daily. In July 2019, the FDA approved the black box warning for the medications Xeljanz and Xeljanz XR. 

Why are people filing lawsuits against the makers of Xeljanz?

The FDA's warning states that users taking the 10 mg twice daily dosage of either Xeljanz or Xeljanz XR are exposed to an increased risk of developing blood clots and an increased risk of early death. Pfizer first ordered the safety trials after an independent panel noticed higher rates of pulmonary embolisms and death rates in the patients prescribed the 10 mg dosage, compared to those receiving the 5 mg dosage.

Am I eligible to file a Xeljanz/Xeljanz XR lawsuit?

Patients (or their surviving family members) who took Xeljanz may be able to file if you suffered: heart attack, stroke, pulmonary embolism, deep venous thrombosis, and/or death. To find out if your case is viable, sign up for a free consultation with The Cochran Firm.

Free Case Evaluation

Please fill out the form below for a free case evaluation

What compensation will I receive?

Each individual case is going to differ in the allowable compensation based on the laws of your state and the facts of your case. In general, however, plaintiffs may be able to receive damages for the following:

  • Medical costs related to the treatment of severe side effects

  • Lost income due to a disability or untimely death

  • Loss of companionship or consortium

  • Funeral expenses for wrongful death

During your free consultation, we will go over any other compensation you may be eligible to receive based on the facts of your case.

How Much Does a Xeljanz/Xeljanz XR Lawyer Cost?

The Cochran Firm  Dothan is taking Xeljanz and Xeljanz XR lawsuits on a contingency basis, meaning that we will only be paid if we help you receive money as part of your legal claim. When talking with us, you should be sure to ask any questions you have about fees and other costs related to your lawsuit.

One final note: 

If you are currently taking Xeljanz or Xeljanz XR, we encourage you to consult with your doctor immediately to re-evaluate whether these medications are the best medications for treating your Rheumatoid Arthritis, Ulcerative Colitis or Psoriatic Arthritis. If you’re using Xeljanz or Xeljanz XR and you experience any of the following symptoms, you should seek immediate emergency medical attention:  

  • Chest Pain that worsens with breathing

  • Shortness of breath

  • Swelling of the arms or legs

  • Leg pain, swelling, and tenderness

  • Red or discolored skin on the legs or arms

 Speak to your healthcare provider before stopping the use of any drugs entirely, as failure to do so can worsen your condition.


The Cochran Firm – Dothan is evaluating cases for individuals and their family members that may have been affected by the dangerous side effects of Xeljanz and Xeljanz XR. Contact us today for a free case evaluation.

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