The Food and Drug Administration says that a safety trial identified a connection between pulmonary embolism and Xeljanz use. The drug may also be linked to other issues such as heart-related problems and cancers, according to recent studies.

The trouble appeared in 2019 in a study of patients taking a 10 mg dose of Xeljanz to treat rheumatoid arthritis. The 10 mg dosage of Xeljanz is not FDA-approved as a treatment for rheumatoid arthritis, though it is approved as a treatment for ulcerative colitis.

Often, the biggest risk for patients is when a drug is used off-label because comprehensive clinical testing and FDA approval has not been done to verify the possible benefits or side effects for patients. However, Xeljanz patients may face serious heart-related problems and cancer, even when taking the drug under approved directions.

What is Xeljanz?

Xeljanz (tofacitinib) works by decreasing the immune system’s activity. It was originally approved in 2012 to assist rheumatoid arthritis adult sufferers who did not appropriately respond to the medicine methotrexate, an immunosuppressant. Since then, the drug has been approved to treat psoriatic arthritis, ulcerative colitis, and, most recently, polyarticular course juvenile idiopathic arthritis—a type of arthritis affecting young children.

Currently, the 10 mg dosage of Xeljanz is only approved for patients who have ulcerative colitis (UC). the U.S. Food and Drug Administration (FDA) has not recommended a twice daily 10 mg dosage for rheumatoid arthritis or psoriatic arthritis.

When Xeljanz was originally approved by the FDA, the agency required a clinical trial among those patients who had rheumatoid arthritis to evaluate risks of cancer, opportunistic infections, and heart-related events.

The analysis of that trial as shared by the FDA found a higher risk of death and pulmonary embolism for those patients treated with double 10 mg doses per day compared with those patients who only took 5 mg twice daily or who were using a comparable TNF inhibitor.

What Are Xeljanz Risks?

In 2019, the FDA has issued a safety alert regarding a clinical study that identified a twice daily 10 mg dose of Xeljanz (tofacitinib) increased the risk of both mortality and pulmonary embolism for patients who have been diagnosed with rheumatoid arthritis.

Following the safety alert, the FDA approved new warning labels for Xeljanz and Xeljanz XR. According to the FDA, a 10 mg twice daily dose of Xeljanz may increase a patient’s risk of experiencing blood clots or death.  As of July 16, 2019, warnings about these serious health side effects have been added to the label and prescribing sheet for Xeljanz and Xeljanz XR.

In addition to adding warnings about these risks, the FDA has also limited the approved use of the medication. Xeljanz is only approved for patients who have not been effectively treated by other medications, or have experienced severe side effects to other drugs. The updates to the label for Xeljanz include a Boxed Warning, the FDA’s most prominent warning.

In the safety trial that prompted the FDA to update the label warnings for Xeljanz, as of January 2018, at least 19 cases of blood clots were found in the lungs of patients who received the drug. Blood clots were only found to have occurred in three of the patients in the study who were given other drugs. Overall, around 45 cases of death were reported from the patients who were given Xeljanz, and 25 cases were reported from patients on other medications.

What Are the Symptoms of a Blood Clot?

Patients taking Xeljanz should report their concerns to a physician immediately if they start to experience blood clot symptoms in their lungs or other unexpected side effects. These include:

• Excessive sweating
• Pain in the back
• Chest pain
• Difficulty breathing
• Bluish color or clammy skin
• Coughing up blood

In addition to the symptoms of a pulmonary embolism, patients who are taking Xeljanz may also want to be aware of the earlier symptoms of blood clots developing in the legs. These symptoms may include leg swelling, pain, redness, warmth to the touch, leg pain when bending the foot, cramps, and skin discoloration.

Are There Other Xeljanz Risks?

In February 2021, the FDA released a new safety alert after data from the same clinical trial found that Xeljanz may be linked to an increased risk of cancers and heart-related conditions. According to Pfizer’s announcement, the most common cancer recorded was lung cancer and the most common heart problem was heart attacks.

Although these risks are only indicated based on preliminary study results, the FDA released the alert to inform both patients and doctors of this connection.

“We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible,” the FDA states.

“We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

Can I File a Xeljanz Lawsuit?

Health care professionals are advised to follow prescription guidance in the labeling of Xeljanz. Patients should be monitored for symptoms and signs of pulmonary embolism, heart problems, and cancers.

However, patients may be able to take further action instead of simply monitoring their risks.

Patients who suffered from pulmonary embolism or other complications after taking Xeljanz may be able to take legal action. A Xeljanz lawsuit can help recover monetary compensation for medical bills, pain and suffering, and even wrongful death.

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