Health Sciences Authority (HSA) announces that, in consultation with its Product Vigilance Advisory Committee, HSA would like to update healthcare professionals on the outcome of its review on the risk of major adverse cardiovascular events, malignancy, thrombosis and death associated with the use of Janus Kinase (JAK) inhibitors for the treatment of inflammatory conditions.
HSA's review concluded that the benefit-risk profile of JAK inhibitors remains positive for their approved indications, where the use of JAK inhibitors is already limited to second line or later therapy in Singapore. Healthcare professionals are advised to consider the benefits and risks of JAK inhibitors before prescribing the drugs, and to monitor their patients for these potential risks during treatment, particularly in patients with risk factors.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/risk-of-major-adverse-cardiovascular-events-malignancy-thrombosis-and-death-associated-with-use-of-janus-kinase-(jak)-inhibitors
In Hong Kong, there are 3 registered pharmaceutical products containing tofacitinib, namely Xeljanz Tablets 5mg (HK-63303), Xeljanz XR Extended Release Tablets 11mg (HK-66141) and Xeljanz Tablets 10mg (HK-66833) which are registered by Pfizer Corporation Hong Kong Limited; 2 products containing baricitinib, namely Olumiant Tablets 2mg (HK-65663) and Olumiant Tablets 4mg (HK-65664) which are registered by Eli Lilly Asia, Inc.; and 2 products containing upadacitinib, namely Rinvoq Prolonged-Release Tablets 15mg (HK-66872) and Rinvoq Prolonged-Release Tablets 30mg (HK-67512) which are registered by Abbvie Limited. All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction related to tofacitinib (9 cases; of which 2 cases were related to cancer and 3 cases were related to deep vein thrombosis), baricitinib (3 cases; of which one case was related to deep vein thrombosis) and upadacitinib (6 cases).
Related news on the risk of blood clots, serious heart-related problems and cancer of JAK inhibitors 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 12 Nov 2022. Letters to inform local healthcare professionals were issued by the DH on 29 Jul 2019, 19 Jun 2020, 15 Jun 2021, 2 Sep 2021 and 31 Oct 2022.
In Dec 2019, the Registration Committee of the Pharmacy and Poisons Board (the Committee) discussed the matter on the risk of blood clots and death associated with the use of tofacitinib, and decided that the sales pack or package insert of tofacitinib products should include safety information about increased risk of blood clots and death with higher dose (10 mg twice daily).
In Dec 2021, the Committee discussed the matter on the risk of venous thromboembolic events (including deep vein thrombosis and pulmonary embolism) associated with the use of JAK inhibitors (tofacitinib, baricitinib and ruxolitinib), and decided that the sales pack or package insert of these products should include the relevant safety information.
As previously reported, the matter will be further discussed by the Committee.
Ends/Friday, Nov 18, 2022
Issued at HKT 15:00
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