Login
Subscribe
March 6, 2019
Here's an important alert for patients taking the oral drug tofacitinib (XELJANZ, XELJANZ XR), which is approved by the Food and Drug Administration (FDA) to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis in certain adult patients.[1]
Tofacitinib is a member of the disease-modifying antirheumatic drug (DMARD) family. DMARDs are drugs that reduce signs and symptoms of rheumatoid arthritis and decrease progression of joint damage. Public Citizen's Health...
March 6, 2019
Here's an important alert for patients taking the oral drug tofacitinib (XELJANZ, XELJANZ XR), which is approved by the Food and Drug Administration (FDA) to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis in certain adult patients.[1]
Tofacitinib is a member of the disease-modifying antirheumatic drug (DMARD) family. DMARDs are drugs that reduce signs and symptoms of rheumatoid arthritis and decrease progression of joint damage. Public Citizen's Health Research Group has designated tofacitinib as Do Not Use for rheumatoid arthritis.[2]
On February 25, the FDA issued a warning about an increased risk of blood clots in the lungs (also known as a pulmonary embolism) and death in rheumatoid arthritis patients taking tofacitinib 10 milligrams (mg) twice daily.[3] Importantly, the highest FDA-approved dosage of Xeljanz for rheumatoid arthritis is 5 mg twice daily; for Xeljanz XR, the highest approved dosage for rheumatoid arthritis is 11 mg once daily.[4] The higher dosage of 10 mg twice daily is approved for certain patients with ulcerative colitis only.
When the FDA first approved tofacitinib in 2012, the agency required the drug's manufacturer to conduct a large randomized clinical trial among rheumatoid arthritis patients to evaluate the risk of heart-related adverse events, cancer and serious infections when the drug is taken at two dosages (10 mg and 5 mg twice daily) in combination with the first-line oral DMARD methotrexate (OTREXUP, RASUVO, TREXALL, XATMEP).[5] The trial also was required to include a comparison group of subjects who instead receive an injectable biologic DMARD known as a tumor necrosis factor (TNF) inhibitor (either adalimumab [AMJEVITA, CYLTEZO, HUMIRA] or etanercept [ENBREL, ERELZI]).[6] For the trial, subjects must be at least 50 years old and have at least one risk factor for cardiovascular disease, such as high cholesterol levels or diabetes.
The trial began in 2014 and is expected to enroll approximately 4,400 subjects and be completed in 2020. A preliminary analysis of data collected so far found a higher occurrence of blood clots in the lungs and death in rheumatoid arthritis subjects taking tofacitinib 10 mg twice daily than in those receiving either tofacitinib 5 mg twice daily or a TNF inhibitor.
The FDA recommended that patients taking tofacitinib seek immediate medical attention if they experience symptoms of a blood clot in the lung. Such symptoms include the following:
- Sudden shortness of breath or difficulty breathing
- Chest or back pain
- Coughing up blood
- Excessive sweating
- Clammy or bluish-colored skin
What You Can Do
If you have rheumatoid arthritis, you should avoid starting tofacitinib if you are not currently taking it. If you are already taking tofacitinib for rheumatoid arthritis, consult with your doctor about switching to another DMARD. DMARDs that we have designated as Limited Use are adalimumab, etanercept, golimumab (SIMPONI), infliximab, anakinra (KINERET), abatacept (ORENCIA) and rituximab (RITUXAN). Do not stop taking any drug before seeing your doctor.
If you are taking tofacitinib for any reason, seek immediate medical evaluation if you experience any of the symptoms listed above.
To see the FDA's safety alert, visit the following link: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm.
References
[1] Pfizer. Label: tofacitinib (XELJANZ). October 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf. Accessed March 5, 2019.
[2] Tofacitinib (XELJANZ): The wrong choice for rheumatoid arthritis. October 2017. https://www.worstpills.org/member/newsletter.cfm?n_id=1155. Accessed March 5, 2019.
[3] Food and Drug Administration. Xeljanz, Xeljanz XR (tofacitinib): Safety communication - safety trial finds increased risk of blood clots in the lungs and death with higher dose in rheumatoid arthritis patients. February 25, 2019. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm. Accessed March 5, 2019.
[4] Pfizer. Label: tofacitinib (XELJANZ). October 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf. Accessed March 5, 2019.
[5] Food and Drug Administration. Xeljanz, Xeljanz XR (tofacitinib): Safety communication - safety trial finds increased risk of blood clots in the lungs and death with higher dose in rheumatoid arthritis patients. February 25, 2019. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm. Accessed March 5, 2019.
[6] ClinicalTrials.gov. Safety study of tofacitinib versus tumor necrosis factor (TNF) inhibitor in subjects with rheumatoid arthritis. https://clinicaltrials.gov/ct2/show/NCT02092467. Accessed March 5, 2019.
