Does Xeljanz Raise Blood Clot Risk?
Yes, Xeljanz (tofacitinib), a JAK inhibitor used for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis, carries a boxed warning for increased risk of blood clots, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis. This risk led the FDA to update its label in 2019 after clinical trials showed higher rates in patients taking higher doses (10 mg twice daily) compared to TNF blockers or placebo.[1][2]
What Do Clinical Trials Show?
In the ORAL Surveillance trial, a postmarketing safety study of over 4,300 rheumatoid arthritis patients aged 50+ with cardiovascular risk factors, Xeljanz at 5 mg or 10 mg twice daily linked to:
- Major adverse cardiovascular events (MACE): 3.4% vs. 2.5% for TNF inhibitors.
- Venous thromboembolism (VTE, including clots): 1.7% vs. 0.7%.
Risk rose with higher doses and longer use. The FDA now recommends lowest effective dose and avoiding in high-risk patients.[1][3]
Who Faces Higher Risk?
Patients over 50 with cardiovascular risks (smoking, high blood pressure, high cholesterol) see elevated rates. Labeling advises monitoring for clot symptoms like leg swelling, chest pain, or shortness of breath. No clots occurred in trials of younger patients without risks, but real-world data shows broader concern.[2][4]
How Does It Compare to Other Drugs?
Xeljanz has higher clot risk than TNF inhibitors like Humira or Enbrel per head-to-head trials. Similar JAK inhibitors (Olumiant, Rinvoq) carry identical boxed warnings. Steroids or NSAIDs pose lower VTE risk but have other issues.[1][5]
What Warnings and Monitoring Are Required?
FDA mandates a boxed warning since 2019. Prescribers must discuss risks; patients need baseline cardiovascular assessment. Discontinue if clots occur. EU regulators issued similar alerts.[2][6]
Can You Still Take It Safely?
Use only if benefits outweigh risks, per lowest dose. Alternatives include biologics or other DMARDs for those with clot history. Consult a doctor for personalized risk via tools like HAS-BLED score.[3][4]
Sources:
[1]: FDA Xeljanz Label
[2]: FDA Drug Safety Communication
[3]: NEJM ORAL Surveillance
[4]: Xeljanz Prescribing Information
[5]: Arthritis Foundation Comparison
[6]: EMA Referral Assessment