The Therapeutic Goods Administration (TGA) has issued a safety alert for tofacitinib following identification of an increased risk of pulmonary embolism and death in a post-marketing study. This safety signal was detected in a cohort of rheumatoid arthritis patients taking 10mg twice daily. These results have not been observed in other clinical trials or post-marketing data.
Tofacitinib is a Janus kinase inhibitor indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Tofacitinib is only approved at a dose of 5mg twice daily for the treatment of rheumatoid arthritis. However, higher doses are approved for treatment induction of ulcerative colitis.
Patients who were taking tofacitinib 10mg twice daily have transitioned to lower doses for the remainder of the study. The sponsor is continuing to work with the TGA to investigate this issue and will provide further details as they come to light. In the interim, healthcare professionals are reminded to follow the recommendations in the product information in relation to the specific condition for which tofacitinib is prescribed. Patients should be advised to seek urgent medical attention if they experience symptoms such as:
- Sudden shortness of breath or difficulty breathing;
- Pain in the chest or back;
- Coughing up blood;
- Excessive sweating; or
- Clammy/bluish coloured
Healthcare professionals and patients are encouraged to report any adverse events or side effects associated with the use of tofacitinib to the TGA.
- Department of Health. Tofacitinib: clinical study finds increased risk of blood clots in the lungs and of death in rheumatoid arthritis patients on high dose. Woden: Therapeutic Goods Administration; 2019.
- Xeljanz® (tofacitinib) Australian approved product information. Sydney: Pfizer Australia. Approved February 2015.