Health Canada announces that an increased incidence rate of thrombosis, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis was observed in patients treated with XELJANZ (tofacitinib) in a large, ongoing post-marketing study (Study A3921133).
In the study, thrombosis, including pulmonary embolism, deep vein thrombosis and arterial thrombosis, was observed at an increased incidence in patients with rheumatoid arthritis. The study showed that rheumatoid arthritis patients aged 50 years or older with at least one cardiovascular (CV) risk factor had a higher rate of all-cause mortality, including sudden CV death, and thrombosis when a 10 mg twice daily dose of XELJANZ was used compared to those treated with XELJANZ 5 mg given twice a day or TNF blockers.
On 15 Mar, 2019, Health Canada announced that it was conducting a safety review after issues were discovered during this ongoing clinical trial. Health Canada has reviewed interim data from this study. To address this safety concern, Health Canada has worked with Pfizer Canada ULC to update the XELJANZ/XELJANZ XR Canadian Product Monograph (CPM). The increased risk of thrombosis has been included in the Serious Warnings and Precautions Box of the XELJANZ/XELJANZ XR CPM. The Adverse Reactions and Consumer Information sections in the CPM have also been updated in relation to this issue.
Before taking XELJANZ/XELJANZ XR, patients should tell their healthcare professional if they:
- have had blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism) or have been told they are at risk of blood clots;
- have problems with their blood clotting (thrombophilia);
- have chest pain (angina pectoris); or
- have heart failure or any heart problems.
Patients taking XELJANZ or XELJANZ XR who develop any signs or symptoms of a blood clot in their leg (such as swelling, pain or tenderness in legs) or in their lung (such as sudden unexplained chest pain or shortness of breath) should stop taking the medication and seek immediate medical help.
Healthcare professionals are advised to:
- Avoid XELJANZ/XELJANZ XR in patients at risk of thrombosis.
- Use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response in patients with ulcerative colitis (UC).
- Use XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily for the treatment of rheumatoid arthritis (RA), and XELJANZ 5 mg twice daily for the treatment of psoriatic arthritis (PsA).
- Monitor for signs and symptoms of thrombosis including deep vein thrombosis, arterial thrombosis, and pulmonary embolism in patients who are taking XELJANZ/XELJANZ XR. If symptoms of deep vein thrombosis, arterial thrombosis, or pulmonary embolism develop, discontinue XELJANZ/XELJANZ XR and promptly evaluate the patient.
- Inform patients about the thrombosis risk with XELJANZ/XELJANZ XR and advise them to seek medical attention immediately if they experience the symptoms listed above.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71766a-eng.php
In Hong Kong, Xeljanz Tablets 5mg (HK-63303) and Xeljanz XR Extended Release Tablets 11mg (HK-66141) are registered pharmaceutical products containing tofacitinib. Both products are registered by Pfizer Corporation Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to tofacitinib, of which one case is related to deep vein thrombosis.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 26 Feb 2019, with the latest update posted on 16 Nov 2019. Letters to inform local healthcare professionals were issued by DH on 29 Jul 2019. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, Dec 3, 2019
Issued at HKT 17:00
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